Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02663232
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'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': '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': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, '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': {'timeFrame': 'This was an epidemiological study with no intervention. Therefore no adverse events were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With V600 BRAF Mutation Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Mutated BRAF', 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000', 'lowerLimit': '35.3', 'upperLimit': '47.5'}]}]}, {'title': 'Wild type', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '64.3'}]}]}, {'title': 'Not available', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '2.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Melanoma Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'IIIc', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'M1a', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}]}]}, {'title': 'M1b', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'M1c', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Melanoma Stage (IIIC \\[referral category\\] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}, {'pValue': '0.196', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Melanoma Stage IIIC/M1a/M1b \\[referral category\\] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}, {'pValue': '0.002', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.', 'statisticalMethod': 'Multivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Multivariate regression analysis of clinical risk factors for BRAF mutation'}, {'pValue': '0.028', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.716', 'ciLowerLimit': '1.115', 'ciUpperLimit': '6.616', 'groupDescription': 'The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.', 'statisticalMethod': 'Multivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)'}, {'pValue': '0.142', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.466', 'ciLowerLimit': '0.168', 'ciUpperLimit': '1.291', 'groupDescription': 'The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.', 'statisticalMethod': 'Multivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)'}, {'pValue': '0.653', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.822', 'ciLowerLimit': '0.351', 'ciUpperLimit': '1.928', 'groupDescription': 'The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.', 'statisticalMethod': 'Multivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Melanoma stages were categorized (according to American Joint Committee on Cancer \\[AJCC\\]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Family History of Melanoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.240', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sun Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Any exposure (n=264)', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}]}]}, {'title': 'Low exposure (n=130)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'Intermittent exposure (n=130)', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000'}]}]}, {'title': 'Chronic exposure (n=130)', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Missing data (n=264)', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.719', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Primary Tumor Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Limbs (Upper extremities)', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Limbs (Lower extremities)', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Trunk', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}]}]}, {'title': 'Head/Neck', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Mucosa', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Uveal', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Acral', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Not available', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.262', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of primary tumor site (trunk \\[referral category\\] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized By LDH Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.313', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of LDH (elevated \\[referral category\\] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Median Time Since Diagnosis of Melanoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '0.291', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of clinical risk factors for BRAF mutation'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'Median time from the diagnosis of primary melanoma to advanced disease was determined in years.', 'unitOfMeasure': 'years', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis except for one participant with missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Metastases', 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000'}]}]}, {'title': 'Primary tumor', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}]}]}, {'title': 'Relapses', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.164', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of tumor sample source (primary tumor \\[referral category\\] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Paraffin-embedded blocks', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}]}]}, {'title': 'Slides of paraffin blocks', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000'}]}]}, {'title': 'Cytological slides', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.505', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of tumor sample type (paraffin-embedded blocks \\[referral category\\] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Buffered formalin', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.701', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of method of fixation (buffered formalin \\[referral category\\] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Breslow Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': '≤1 mm', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': '1.01 - 2.0 mm', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}]}]}, {'title': '2.01 - 4.0 mm', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000'}]}]}, {'title': '>4 mm', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.683', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Berslow thickness (≤1 mm \\[referral category\\] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (\\>) 4.0 mm and Unknown.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Ulceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'With ulceration', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}]}]}, {'title': 'Without ulceration', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Ulceration (no \\[referral category\\] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Regression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'With regression', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Without regression', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.949', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of presence of regression (Without regression \\[referral category\\] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vascular Invasion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'With vascular invasion', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Without vascular invasion', 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.374', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The association of Vascular invasion (Without vascular invasion \\[referral category\\] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.', 'statisticalMethod': 'Bivariate regression analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Bivariate regression analysis of anatomopathological risk factors for BRAF mutation'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Cobas® BRAF V600 Mutation Test', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': 'Cobas® 4800 BRAF V600 Mutation Test', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'title': '<60%', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}]}]}, {'title': '60-80%', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': '>80%', 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The samples were classified based on the percentage of tumor cells referred to the technique as follows: \\<60 percent (%), 60-80%, \\>80% and Unknown.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adequate Quality/Quantity of Tumor Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Metastatic Melanoma', 'description': 'Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '56.0', 'upperLimit': '77.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants enrolled in the study were included in the analysis.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2015-11-20', 'resultsFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-03', 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With V600 BRAF Mutation Status', 'timeFrame': 'Day 1', 'description': 'Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Categorized by Melanoma Stage', 'timeFrame': 'Day 1', 'description': 'Melanoma stages were categorized (according to American Joint Committee on Cancer \\[AJCC\\]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.'}, {'measure': 'Percentage of Participants With Family History of Melanoma', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants With Sun Exposure', 'timeFrame': 'Day 1', 'description': 'Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.'}, {'measure': 'Percentage of Participants Categorized by Primary Tumor Location', 'timeFrame': 'Day 1', 'description': 'Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.'}, {'measure': 'Percentage of Participants Categorized By LDH Level', 'timeFrame': 'Day 1', 'description': 'Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.'}, {'measure': 'Median Time Since Diagnosis of Melanoma', 'timeFrame': 'Day 1', 'description': 'Median time from the diagnosis of primary melanoma to advanced disease was determined in years.'}, {'measure': 'Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants Categorized by Breslow Thickness', 'timeFrame': 'Day 1', 'description': 'Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (\\>) 4.0 mm and Unknown.'}, {'measure': 'Percentage of Participants With Ulceration', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants With Regression', 'timeFrame': 'Day 1', 'description': 'Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.'}, {'measure': 'Percentage of Participants With Vascular Invasion', 'timeFrame': 'Day 1', 'description': 'Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.'}, {'measure': 'Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)', 'timeFrame': 'Day 1'}, {'measure': 'Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique', 'timeFrame': 'Day 1', 'description': 'The samples were classified based on the percentage of tumor cells referred to the technique as follows: \\<60 percent (%), 60-80%, \\>80% and Unknown.'}, {'measure': 'Percentage of Participants With Adequate Quality/Quantity of Tumor Sample', 'timeFrame': 'Day 1'}]}, 'conditionsModule': {'keywords': ['V600 BRAF mutation', 'Metastatic melanoma'], 'conditions': ['Metastatic Cancers']}, 'descriptionModule': {'briefSummary': 'This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with metastatic melanoma who have valid samples for BRAF mutation testing and give their informed consent will be included in this trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma\n* Written informed consent granted\n\nExclusion Criteria:\n\n\\- Do not fulfill one or more inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02663232', 'briefTitle': 'Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Epidemiological Study of V600 BRAF Mutation in Spanish Patients Diagnosed With Metastatic Melanoma: ABSOLUT-BRAF Study', 'orgStudyIdInfo': {'id': 'ML30089'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metastatic melanoma', 'description': 'Participants with metastatic melanoma who attend their physicians during the 18-month recruitment period and have valid biological samples available for BRAF mutation testing will be included in the study. There will be no intervention in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cadiz', 'country': 'Spain', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '12002', 'city': 'Castellon', 'state': 'Castellon', 'country': 'Spain', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '20080', 'city': 'Donostia / San Sebastian', 'state': 'Guipuzcoa', 'country': 'Spain', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'LA Coruña', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '30202', 'city': 'Cartagena (Murcia)', 'state': 'Murcia', 'country': 'Spain', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '10003', 'city': 'Cáceres', 'country': 'Spain', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28002', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '41014', 'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}