Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT03952793
Status:
TERMINATED
Last Update Posted:
2021-11-01
First Post:
2019-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organoids From Metastases of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Feasibility issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of establishment of the organoid culture', 'timeFrame': '15 days', 'description': 'The success rate is defined by the rate of successful cell culture. A Cell culture is successful when organoids grow from dividing cells'}], 'secondaryOutcomes': [{'measure': 'Drugs testing on organoid for cell viability', 'timeFrame': '20 days', 'description': 'Viable cell count in different cells culture conditions using Cell titer Glo and viable cell count using typan blue'}, {'measure': 'Cell Apoptosis Molecular and cellular mechanisms of drugs responses', 'timeFrame': '20 days', 'description': 'Apoptosis biomarkers analysis in microscopy. Caspase 3 will be assess using microspcopy .'}, {'measure': 'Cell proliferation Molecular and cellular on mechanisms of drugs responses', 'timeFrame': '20 days', 'description': 'Proliferative biomarkers analysis in microscopy. Ki67 will be assess using microspcopy .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'The aim of the study is the development of the organoid culture technique from metastases from patients with advanced form of prostate cancer. Once the technique is set up, the organoid will serve to test several antitumor molecules.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with metastatic prostate cancer\n* Patient having a biopsy programmed as part of his care.\n* Patient having a biopsy programmed as part of hiscare.\n* Patient with sufficient tumor volume after imaging data review by the radiologist to guarantee a sufficient quantity of material for the diagnosis of biopsy and additional material for the study.\n* INR \\<1.5; Platelets \\> 50000 / μL\n\nExclusion Criteria:\n\n* Patient under age of 18 years.\n* Patient under Plavix or Effient or Ticlid without possibility of suspension for 5 days, low molecular weight heparin without possibility of suspension of the dose before the intervention, or Fondaparinux without possibility of suspension, or ReoPro without possibility of suspension for 24h and aPTT \\<50s and ACT \\<150s, or Integrilin or Aggrastat or Argatroban without possibility of suspension 4 H before the intervention, or Angiomax without possibility of suspending 2H to 3H if CrCL\\> 50 mL / min or 3H to 5h if CrCL \\<50 mL / min before the intervention or and Pradaxa without possibility of suspension 2 to 3 days if CrCL\\> 50 mL / min or 3 to 5 days if CrCL \\<50 mL / min before the procedure\n* Patient under desmopressin acetate (DDAVP)\n* Patient with HIV or Hepatitis C positive or Hepatitis B infection, defined by either a detection of the HBs antigen or the presence of anti HBc antibodies without HBs antibody detectable.'}, 'identificationModule': {'nctId': 'NCT03952793', 'acronym': 'OrMePro', 'briefTitle': 'Organoids From Metastases of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Antoine Lacassagne'}, 'officialTitle': 'Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research', 'orgStudyIdInfo': {'id': '2018/63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Extended biopsy', 'interventionNames': ['Other: extended biopsy']}], 'interventions': [{'name': 'extended biopsy', 'type': 'OTHER', 'description': 'Additional sample are performed during a biopsy to provide tumor tissues for the organoid technique development', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Antoine Lacassagne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Méditerranéen de Médecine Moléculaire UMR_S-1065', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}