Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT04675320
Status:
UNKNOWN
Last Update Posted:
2023-12-07
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
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'}]}, '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': '5 specific blood samples :\n\n* On the first day of anti-PARP treatment (before taking the first dose)\n* Second month of anti-PARP treatment\n* Fourth month of anti-PARP treatment\n* Sixth month of anti-PARP treatment\n* At relapse or cessation of anti-PARP treatment\n\nFor each blood sample\n\n* 1 heparinized tube (5 mL) for plasmatheque\n* 1 heparinized tube (5 mL) for immunophenotyping,\n* 4 EDTA tubes (4 x 10 mL) for PBMC collection (cryopreservation).\n* 1 EDTA tube (10mL) for quantification of circulating tumor DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune response in plasma', 'timeFrame': 'From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months', 'description': 'Realization of a plasma library'}, {'measure': 'Immune response in PBMC', 'timeFrame': 'From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months', 'description': 'Realization of a PBMC bank'}, {'measure': 'Immune response in tumor DNA', 'timeFrame': 'From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months', 'description': 'Realization of a circulating tumor DNA bank'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARP Inhibitors', 'immunomonitoring'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.', 'detailedDescription': 'The aim is to assess the impact of anti-PARP on peripheral immune populations and the amount of DNA circulating; to correlate these data with tumor infiltration, with the initial clinical characteristics and with the clinical course; compare the immunogenic effect of different anti-PARPs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Cohort 1: Maintenance treatment of adult patients with newly diagnosed BRCA1/2-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) who have had a partial or complete response to first-line platinum-based chemotherapy. BRCA-mutated epithelial ovarian cancer - maintenance with Olaparib / Niraparib or Olaparib + bevacizumab\n* Cohort 2: Single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who are responding (complete or partial) to platinum-based chemotherapy. Recurrent epithelial ovarian cancer - maintenance with Niraparib or Olaparib', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient over 18 years\n2. Patient treated for epithelial ovarian cancer\n3. Eligible for anti-PARP therapy and in one of the 2 cohorts below:\n\n * Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy.\n * 2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.\n4. Patient having signed the informed consent form.\n5. Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.\n6. Patient affiliated to the social security system.\n\nExclusion Criteria:\n\n1. Non-epithelial tumour of the ovary\n2. Patient unable to understand, read and/or sign informed consent.\n3. Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions.\n4. Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.\n5. Pregnant or breast-feeding women.\n6. HIV and/or HBV and/or HCV serology positive.\n7. Patient refusal.\n8. Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).\n9. Inability to undergo medical follow-up for geographical, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT04675320', 'acronym': 'IMMUNOPARP', 'briefTitle': 'Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Centre Georges Francois Leclerc'}, 'officialTitle': 'Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors', 'orgStudyIdInfo': {'id': '2020-A00036-33'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First-line epithelial ovarian cancer (30 patients)', 'description': 'Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation who have had a partial or complete response to first-line platinum-based chemotherapy.', 'interventionNames': ['Biological: blood samples']}, {'label': 'Recurrent epithelial ovarian cancer (20 patients)', 'description': 'Single-agent maintenance treatment of adult patients with primary, recurrent, platinum-sensitive epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.', 'interventionNames': ['Biological: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'BIOLOGICAL', 'description': 'Blood sampling during PARP inhibitor therapy', 'armGroupLabels': ['First-line epithelial ovarian cancer (30 patients)', 'Recurrent epithelial ovarian cancer (20 patients)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Georges Francois Leclerc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}