Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 1:50 PM
Study NCT ID:
NCT00346008
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2006-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}], 'ancestors': [{'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2006-06-27', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility to identify melanoma'}, {'measure': 'Feasibility to detect mutation'}, {'measure': 'Ability to create datasets'}]}, 'conditionsModule': {'keywords': ['melanoma', 'recurrent melanoma', 'stage I melanoma', 'stage II melanoma', 'stage III melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and their family members may help doctors identify biomarkers related to cancer.\n\nPURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland and their family members.', 'detailedDescription': "OBJECTIVES:\n\n* Assess the feasibility of Iceland Genomics Corporation (UVS) to identify melanoma in multiple-case families, individuals with multiple tumors, and selected additional family members in Iceland.\n* Assess the feasibility of mutation detection using sequencing and HPLC.\n* Determine UVS' ability to create datasets with demographic, epidemiologic and molecular data.\n\nOUTLINE: Participants and patients undergo blood collection and complete lifestyle questionnaires. All patients and population-based controls have DNA samples sequenced for MC1R. Demographic and epidemiologic data on all study participants is collected. Sequencing of the major melanoma susceptibility genes CFDKN2A, CDK4, and MC1R is also performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients diagnosed with melanoma and selected family members are eligible to participate\n* Must live in Iceland\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00346008', 'briefTitle': 'Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members', 'nctIdAliases': ['NCT00482534'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Genetic Epidemiologic Studies of Melanoma in Iceland', 'orgStudyIdInfo': {'id': 'NBCI-03-033-CM'}, 'secondaryIdInfos': [{'id': 'NCI-06-C-N026'}, {'id': 'CDR0000551606', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NBCI-01-087-CM'}, {'id': '999906026'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'mutation analysis', 'type': 'GENETIC'}, {'name': 'high performance liquid chromatography', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '105', 'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'Iceland Genomics Corporation', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}], 'overallOfficials': [{'name': 'Alisa Goldstein, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iceland Genomics Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}