Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT01482260
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2011-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096142', 'term': 'Melanoma, Cutaneous Malignant'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'skin biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-05', 'studyFirstSubmitDate': '2011-11-26', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cutaneous Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '23111773', 'type': 'RESULT', 'citation': 'Sand M, Skrygan M, Sand D, Georgas D, Gambichler T, Hahn SA, Altmeyer P, Bechara FG. Comparative microarray analysis of microRNA expression profiles in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases, and benign melanocytic nevi. Cell Tissue Res. 2013 Jan;351(1):85-98. doi: 10.1007/s00441-012-1514-5. Epub 2012 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.', 'detailedDescription': 'Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with\n\n* Primary Cutaneous Malignant Melanoma\n* Cutaneous Malignant Melanoma Metastases\n* Benign Melanocytic Naevi', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Cutaneous Malignant Melanoma\n* Cutaneous Malignant Melanoma Metastases\n* Benign Melanocytic Naevi\n\nExclusion Criteria:\n\n\\- Other Skin Cancer than Primary Cutaneous Malignant Melanoma'}, 'identificationModule': {'nctId': 'NCT01482260', 'briefTitle': 'Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Comparative Microarray Analysis of microRNA Expression Profiles in Primary Cutaneous Malignant Melanoma, Cutaneous Malignant Melanoma Metastases and Benign Melanocytic Naevi', 'orgStudyIdInfo': {'id': 'microRNA5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Cutaneous Malignant Melanoma', 'interventionNames': ['Procedure: Biopsy']}, {'label': 'Cutaneous Malignant Melanoma Metastases', 'interventionNames': ['Procedure: Biopsy']}, {'label': 'Benign Melanocytic Nevi', 'interventionNames': ['Procedure: Biopsy']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy', 'armGroupLabels': ['Benign Melanocytic Nevi', 'Cutaneous Malignant Melanoma Metastases', 'Primary Cutaneous Malignant Melanoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Falk G Bechara, PD Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum'}, {'name': 'Peter Altmeyer, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Sand', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}