Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-12 @ 1:05 AM
Study NCT ID:
NCT03319693
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2017-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characterization of Primary Mucosal Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015316', 'term': 'Genetic Therapy'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of main mutations identified using the NGS panel', 'timeFrame': 'Day 0', 'description': 'NGS panel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mucosal Melanoma']}, 'descriptionModule': {'briefSummary': 'Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM.\n\nThe principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with MPM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014\n\nExclusion criteria:\n\n* Cutaneous melanoma\n* Uveal melanoma'}, 'identificationModule': {'nctId': 'NCT03319693', 'acronym': 'MELMUQ', 'briefTitle': 'Molecular Characterization of Primary Mucosal Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Molecular Characterization of Primary Mucosal Melanoma', 'orgStudyIdInfo': {'id': 'PA16108*'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mucosal melanoma', 'description': 'Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014', 'interventionNames': ['Genetic: Somatic Genetic']}], 'interventions': [{'name': 'Somatic Genetic', 'type': 'GENETIC', 'description': 'NGS analysis', 'armGroupLabels': ['Mucosal melanoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}