Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT02297958
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2014-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response', 'timeFrame': 'surgery', 'description': 'Main outcome is cleaved FasL level and correlation with neoadjuvant chemotherapy tumor response, evaluated during surgery.'}], 'secondaryOutcomes': [{'measure': 'Identification of tumoral T cells', 'timeFrame': 'surgery', 'description': 'Identification of tumoral T cells with FACS analysis of dissociated tumor. Different T cells will be studies: Treg/Th17/Th1/Th2 using antibodies against: CD45/CD3/CD4/CD25/FOXP3 (Treg), CD45/CD3/CD4/IL17A (Th17), CD45/CD3/CD4/CD8/IL4/INF (TCD8 and LTCD4 Th1 et Th2).'}, {'measure': 'Disease Free Survival rate', 'timeFrame': '18 months after surgery'}, {'measure': 'Overall survival rate', 'timeFrame': '18 months after surgery'}]}, 'conditionsModule': {'conditions': ['Ovarian Carcinoma']}, 'descriptionModule': {'briefSummary': 'Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with ovarian carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pre-Inclusion Criteria:\n\n\\- Patient with suspicious ovarian carcinoma using clinical data, biological data (ca125) and radiological data (CT)\n\nInclusion Criteria:\n\n* Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.\n* Neo adjuvant chemotherapy\n\nExclusion Criteria:\n\n* no neo-adjuvant chemotherapy\n* no ovarian carcinoma at final pathological analysis\n* less than 18 years old.'}, 'identificationModule': {'nctId': 'NCT02297958', 'acronym': 'IFFaLCCO', 'briefTitle': 'Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma', 'orgStudyIdInfo': {'id': '2014-A01041-46'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rennes', 'country': 'France', 'facility': 'Service de Gynécologie', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Vincent Lavoue, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}