Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT01744860
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2012-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '+41 61 6878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'As the samples were used instead of participants for analysis there were no serious or non-serious adverse events reported.', 'eventGroups': [{'id': 'EG000', 'title': 'INCa Molecular Genetics Laboratory "in House" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using in-house methods', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "in House" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}, {'id': 'OG001', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}], 'classes': [{'title': 'BRAF V600 mutation- Yes', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'BRAF V600 mutation - No', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}, {'title': 'Non evaluable', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Type of mutation, V600D, n = 150', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Type of BRAF V600 mutation could not be detected by this method', 'groupId': 'OG001'}]}]}, {'title': 'Type of mutation, V600E, n = 150', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Type of BRAF V600 mutation could not be detected by this method', 'groupId': 'OG001'}]}]}, {'title': 'Type of mutation, V600K, n = 150', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Type of BRAF V600 mutation could not be detected by this method', 'groupId': 'OG001'}]}]}, {'title': 'Type of mutation, V600R, n = 150', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Type of BRAF V600 mutation could not be detected by this method', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Kappa coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8611', 'ciLowerLimit': '0.8125', 'ciUpperLimit': '0.9097', 'groupDescription': 'Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory "in-house" methods and Cobas 4800 Mutation Test.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. n = number of samples with BRAF V600 mutation by "in-house method".'}, {'type': 'SECONDARY', 'title': 'Tumor Sample Characteristics-Type of Tumor Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Tumour Samples', 'description': 'A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories'}], 'classes': [{'title': 'Biopsy', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Surgical specimen', 'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis'}, {'type': 'SECONDARY', 'title': 'Tumor Sample Characteristics - Source of Tumor Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Tumour Samples', 'description': 'A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories'}], 'classes': [{'title': 'External pathology laboratory', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}]}]}, {'title': 'Internal pathology laboratory', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'title': 'External pathology laboratory', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}]}]}, {'title': 'Internal pathology laboratory', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Time From Sampling to Fixation- Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'title': '0-2 hours', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}]}]}, {'title': '2-6 hours', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': '>6 hours', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, \\>6 hours and unknown. Number of samples falling in each of the class were reported.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Type of Fixative Used- Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'title': 'Alcohol Formol Acetic acid (AFA)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Excell', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Formol', 'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Fixation Duration by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'title': '<6 hours', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '6-24 hours', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': '>24 hours', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as \\<6 hours, 6-24 hours and \\>24 hours and unknown. Number of samples falling in each category were reported', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Slice Thickness by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.', 'unitOfMeasure': 'micrometer (µm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Dewaxing by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 Months', 'description': 'Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as "Yes, No or Missing"', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Necrosis Percentage Determination by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '341', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only 341 samples out of 420 were analysed as the information on presence of necrosis was missing for 79 samples in the assessed zones.'}, {'type': 'SECONDARY', 'title': 'Percentage of Tumor Cells by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'spread': '20.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'The percentage of tumor cells in the given tumor sample were reported.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Tumor Samples With Presence of Melanin by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'title': 'Few', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}]}]}, {'title': 'Medium', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Important', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Absent', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only available samples were included for analysis.'}, {'type': 'SECONDARY', 'title': 'DNA Extraction - Extraction Method by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'title': 'Automated extraction method', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'Manual extraction method', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Median DNA Elution Volume by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '185'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'Median DNA elution volume microliters \\[mcl\\] was reported.', 'unitOfMeasure': 'mcl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean DNA Concentration by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '155.25', 'spread': '206.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).', 'unitOfMeasure': 'ng/mcl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Amount of DNA by Pre-analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "in House" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '11816', 'spread': '14407', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'The total DNA concentration extracted from the tissue was measured in nanogram (ng).', 'unitOfMeasure': 'ng', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Size of Amplicons Used by "In-house" Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '232'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'The method described the size of amplicon used. It was measured in base pairs (bp).', 'unitOfMeasure': 'bp', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Method of Mutation Detection by "In-house" Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'title': 'Allele-specific PCR', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'HRM + Sanger sequencing', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Pyrosequencing', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Real time PCR', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'SNaPshot', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Sanger sequencing', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Samples Punched in In-house Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': "Total number of samples for whom punch was used in 'in-house analytical' method are reported.", 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Slices Per Sample Used for "In-house"- Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'The mean of number of slices per sample when no punch was used are reported.', 'unitOfMeasure': 'number of samples', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was not used were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INCa Molecular Genetics Laboratory "In-house" Methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}], 'classes': [{'categories': [{'measurements': [{'value': '64.62', 'spread': '78.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)', 'unitOfMeasure': 'ng/mcl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.', 'unitOfMeasure': 'number of samples', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was No=375, was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months', 'description': 'This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Management of Discordance- Method Used to Manage Discordance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discordant Group', 'description': 'This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa "in House" Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.'}], 'classes': [{'title': 'Crossing DNA', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'DNA from In-House method analysed with cobas', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'SNaPshot', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'DNA from cobas analysed with In-House method', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'External site control test', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Sanger sequencing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Kit CE-IVD Therascreen RGQ Qiagen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'KIT THERASCREEN RGQ BRAF+PYROSEQ. by other PF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pyrosequencing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mutation detection on other Block, (prm. tmr)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sequencing and Therascreen kit (Qiagen)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor \\[prm. tmr\\]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between "in-house" method and Cobas 4800 mutation test.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the "in-house" method did not show similar outcome with the cobas 4800 mutation test.'}, {'type': 'SECONDARY', 'title': 'Management of Discordance-Final Result for BRAF V600 Mutation Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'Tumor Samples', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Result- Discordant Samples', 'description': 'This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa "in House" Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.'}], 'classes': [{'title': 'BRAF V600 mutation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'No BRAF V600 mutation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Non evaluable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.', 'unitOfMeasure': 'number of samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tumor Samples', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the "in-house" method did not show similar outcome with the cobas 4800 mutation test.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melanoma Tumor Sample With BRAF V600 Mutation', 'description': 'BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods and Cobas 4800 mutation test'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '420'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '420'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted from 12 December 2012 to 03 April 2013 which evaluated 420 samples for detection of BRAF V600 mutation in France laboratories.', 'preAssignmentDetails': 'A total 420 melanoma tumor samples were analysed in 12 platform laboratories in France. The paraffin-embedded tumour samples were taken from biopsy or surgical specimen from the internal or external pathology laboratory.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Melanoma Tumor Sample With BRAF V600 Mutation', 'description': 'BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods and Cobas 4800 mutation test'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': 'NA', 'comment': 'This study has analysed sample data rather than participants', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': 'NA', 'comment': 'This study has analysed sample data rather than participants', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': 'NA', 'comment': 'This study has analysed sample data rather than participants', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Biological samples were analysed rather than samples'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2012-12-06', 'resultsFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-25', 'studyFirstPostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories', 'timeFrame': 'Up to 6 months', 'description': 'BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.'}], 'secondaryOutcomes': [{'measure': 'Tumor Sample Characteristics-Type of Tumor Sample', 'timeFrame': 'Up to 6 months', 'description': 'The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported'}, {'measure': 'Tumor Sample Characteristics - Source of Tumor Sample', 'timeFrame': 'Up to 6 months', 'description': 'The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported'}, {'measure': 'Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.'}, {'measure': 'Time From Sampling to Fixation- Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, \\>6 hours and unknown. Number of samples falling in each of the class were reported.'}, {'measure': 'Type of Fixative Used- Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.'}, {'measure': 'Fixation Duration by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as \\<6 hours, 6-24 hours and \\>24 hours and unknown. Number of samples falling in each category were reported'}, {'measure': 'Slice Thickness by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.'}, {'measure': 'Dewaxing by Pre-analytical Method', 'timeFrame': 'Up to 6 Months', 'description': 'Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as "Yes, No or Missing"'}, {'measure': 'Necrosis Percentage Determination by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.'}, {'measure': 'Percentage of Tumor Cells by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The percentage of tumor cells in the given tumor sample were reported.'}, {'measure': 'Tumor Samples With Presence of Melanin by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.'}, {'measure': 'DNA Extraction - Extraction Method by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.'}, {'measure': 'Median DNA Elution Volume by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'Median DNA elution volume microliters \\[mcl\\] was reported.'}, {'measure': 'Mean DNA Concentration by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).'}, {'measure': 'Amount of DNA by Pre-analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The total DNA concentration extracted from the tissue was measured in nanogram (ng).'}, {'measure': 'Size of Amplicons Used by "In-house" Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The method described the size of amplicon used. It was measured in base pairs (bp).'}, {'measure': 'Method of Mutation Detection by "In-house" Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.'}, {'measure': 'Number of Samples Punched in In-house Analytical Method', 'timeFrame': 'Up to 6 months', 'description': "Total number of samples for whom punch was used in 'in-house analytical' method are reported."}, {'measure': 'Mean Number of Slices Per Sample Used for "In-house"- Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The mean of number of slices per sample when no punch was used are reported.'}, {'measure': 'Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.'}, {'measure': 'Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.'}, {'measure': 'Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)'}, {'measure': 'Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.'}, {'measure': 'Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.'}, {'measure': 'Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.'}, {'measure': 'Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method', 'timeFrame': 'Up to 6 months', 'description': 'This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.'}, {'measure': 'Management of Discordance- Method Used to Manage Discordance', 'timeFrame': 'Up to 6 months', 'description': 'Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor \\[prm. tmr\\]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between "in-house" method and Cobas 4800 mutation test.'}, {'measure': 'Management of Discordance-Final Result for BRAF V600 Mutation Detection', 'timeFrame': 'Up to 6 months', 'description': 'The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.'}]}, 'conditionsModule': {'conditions': ['Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'No patients are enrolled in this study. Use of melanoma tumor samples.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNo patients are enrolled. Use of tumor samples only.\n\n* Histologically proven melanoma tumor sample\n* Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis\n* Tumor samples must be fixed and paraffin-embedded.\n\nExclusion Criteria:\n\nNo patients are enrolled. Use of tumor samples only.\n\n* Fixative unknown'}, 'identificationModule': {'nctId': 'NCT01744860', 'briefTitle': 'Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Evaluation of Concordance Between the Methods Used in INCa Platforms and the Cobas® 4800 BRAF V600 Mutation Test for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting', 'orgStudyIdInfo': {'id': 'ML28471'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'INCa molecular genetics laboratory "in-house" methods', 'description': 'BRAF V600 mutations were analysed using INCa (Institut National du Cancer \\[French National Cancer Institute\\]) molecular genetics laboratories using "in-house" methods'}, {'label': 'Cobas 4800 Mutation Test', 'description': 'BRAF V600 mutations were analysed using Cobas 4800 mutation test'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92104', 'city': 'Boulogne-Billancourt', 'country': 'France', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94505', 'city': 'Villejuif', 'country': 'France', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}