Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-02 @ 2:16 PM
Study NCT ID:
NCT02095912
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2014-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-09', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Transplantation history', 'timeFrame': '1 year', 'description': 'Measurements will be assessed with questionnaire from about 150 participants.'}], 'primaryOutcomes': [{'measure': 'Diameter of Squamous Cell Carcinoma', 'timeFrame': '1 year', 'description': '* Location\n* exact size in mm\n* histological classification (well-differentiated, moderately-differentiated, poorly differentiated, spindle cell morphology, desmoplastic, basi-squamous, acantholytic)\n* Invasion\n* rapid growth\n* local recurrence\n* sentinel node sampling\n* Metastasis'}], 'secondaryOutcomes': [{'measure': 'Sun exposure history', 'timeFrame': '1 year', 'description': '* skin type\n* hair colour\n* eye colour\n* freckles\n* cumulative UV exposure\n\nMeasurements will be assessed with questionnaire from about 150 participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Squamous Cell Carcinoma'], 'conditions': ['Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.', 'detailedDescription': 'Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC.\n\nUnfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis.\n\nThe aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Organ Transplant Recipients with:\n\n* \\> 9 Squamous Cell Carcinoma (SCC) in total or\n* \\> 2 SCC per year (in any one year) or\n* any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOrgan transplant recipients with:\n\n* \\> 9 SCC in total or\n* \\> 2 SCC per year (in any one year) or\n* any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis\n\nExclusion Criteria:\n\n* Non organ transplant recipients'}, 'identificationModule': {'nctId': 'NCT02095912', 'briefTitle': 'Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients', 'orgStudyIdInfo': {'id': 'KEK-ZH-2013-0591'}}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Guenther Hofbauer, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}