Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-04-02 @ 10:45 AM
Study NCT ID:
NCT01440504
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2011-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2011-09-23', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of apoptotic cells', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'Ovarian', 'chemotherapy', 'BH3-mimetic', 'platin', 'ex-vivo'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to quantify the ex vivo induction of apoptosis by ABT-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient, any chemotherapy naive or ovarian surgery, ovarian cancer with at least five tumor samples does not affect the diagnostic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged over 18 years\n* Ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses\n* Surgery of any initial chemotherapy naive\n* Patient information and signed informed consent\n\nExclusion Criteria:\n\n* A person deprived of liberty or under guardianship\n* Insufficient tumor samples of ovarian cancer.'}, 'identificationModule': {'nctId': 'NCT01440504', 'acronym': 'ABT737 exvivo', 'briefTitle': 'Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Ex Vivo Evaluation of the Interest of the Association of Platinum With a Molecule BH3-mimetic ABT-737 in Samples of Ovarian Tumors', 'orgStudyIdInfo': {'id': 'ABT-737 ex vivo'}}, 'armsInterventionsModule': {'interventions': [{'name': 'culture ex vivo with exposure to different therapeutic agents alone or in combination.', 'type': 'OTHER', 'description': 'When tumor resection, tumor specimens of ovarian cancer will be made towards a culture ex vivo with exposure to different therapeutic agents alone or in combination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'JOLY Florence, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre françois Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'GRECAN', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}