Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06603506
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of establishment of exploitable tumor organoid lines', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Rate of establishment of tumor organoid lines usable for predictive assays of response to PARP inhibitors.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometrial cancer', 'organoide', 'PARP inhibitor'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '39934735', 'type': 'DERIVED', 'citation': 'Gall GL, Cherifi F, Divoux J, Florent R, Christy F, Leconte A, San C, Devillers A, Desmartin G, Lecouflet L, Clarisse B, Ballesta S, Thorel L, Dubois B, Harter V, Rousseau N, Gaichies L, Martin-Francoise S, Le Brun JF, Dolivet E, Rouzier R, Jeanne C, Blanc-Fournier C, Figeac M, Leman R, Castera L, Poulain L, Weiswald LB, Joly F. The PENDOR study: establishment of a panel of patient-derived tumor organoids from endometrial cancer to assess efficacy of PARP inhibitors. BMC Cancer. 2025 Feb 11;25(1):244. doi: 10.1186/s12885-025-13590-6.'}]}, 'descriptionModule': {'briefSummary': 'This study comprises 3 stages:\n\n1. Collection of tumor and blood samples.\n2. Creation of organoid models based on tumor samples.\n3. Development of functional tests to predict clinical response to treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with localized endometrial cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 years or more\n* Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.\n* Patient with localized endometrial cancer, presenting:\n\n * A high-grade endometrioid histological type and/or\n * P53 mutation and/or\n * a non-endometrioid histological type regardless of P53 status.\n* Patient affiliated to a social security scheme\n* Information and signature of informed consent prior to any specific study procedure\n\nExclusion Criteria:\n\n* Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).\n* Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.'}, 'identificationModule': {'nctId': 'NCT06603506', 'acronym': 'PENDOR', 'briefTitle': 'Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study', 'orgStudyIdInfo': {'id': '2024-A01206-41'}, 'secondaryIdInfos': [{'id': '2024-A01206-41', 'type': 'OTHER', 'domain': 'ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'tumour and blood collection', 'description': 'tumour and blood collection for realization ex vivo organoid models', 'interventionNames': ['Other: tumour and blood samples']}], 'interventions': [{'name': 'tumour and blood samples', 'type': 'OTHER', 'description': 'Tumour and blood samples', 'armGroupLabels': ['tumour and blood collection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenn LE GALL, Medical Doctor', 'role': 'CONTACT', 'email': 'g.legall@baclesse.unicancer.fr', 'phone': '332031455050'}], 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Gwenn LE GALL, Medical Doctor', 'role': 'CONTACT', 'email': 'g.legall@baclesse.unicancer.fr', 'phone': '+33231455050'}, {'name': 'François CHERIFI, Medical Doctor', 'role': 'CONTACT', 'email': 'f.cherifi@baclesse.unicancer.fr', 'phone': '33231455050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}