Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-03 @ 10:22 AM
Study NCT ID:
NCT01942005
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2013-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blutsample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.', 'timeFrame': '7 years'}], 'secondaryOutcomes': [{'measure': 'correlation between possibly detected mutation/specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen and a composite of kind and number of neoplasm, age of patients, UV burden, duration and kind of immunosuppression.', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Immunosuppression', 'Neoplasm']}, 'descriptionModule': {'briefSummary': 'Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.', 'detailedDescription': 'correlation between possibly detected mutation/specific polymorphism and kind and number of neoplasm, age of patients, UV burden, duration and kind of immunosuppression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent organ transplatation or patients who have a HIV infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in an immunosuppressive condition either by immunosuppressants or by HIV infection\n\nExclusion Criteria:\n\n* written informed consent not given'}, 'identificationModule': {'nctId': 'NCT01942005', 'acronym': 'EBVER/TMC', 'briefTitle': 'EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients,Especially Patients After Organ Transplantation and Patients With HIV Infection', 'orgStudyIdInfo': {'id': '11/10'}}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Dermatology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Andreas Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Dermatology, CH-4031 Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andreas Arnold', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Andreas Arnold, senior physician', 'investigatorFullName': 'Andreas Arnold', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}