Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06065358
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test the effect of chemotherapeutic drugs on ovarian cancer cell cultures.', 'timeFrame': '24 months', 'description': 'To evaluate the concordance of chemotherapy drug response in ovarian cancer patients treated in vivo and in cell culture of tumor tissue harvested and treated in vitro.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': "Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.\n\nFor these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.", 'detailedDescription': "Most patients with ovarian cancer (OC) present with advanced stage and severe symptoms. The standard of care is based on an association between surgery and platinum-based chemotherapy, to which targeted therapies have been added since 2014. Despite significantly improved outcomes, there are still 15-20% of patients resistant to platinum-based chemotherapy without many therapeutic options and poor prognosis. It is urgent to select this population thus limiting useless undesirable effects and exploring more effective therapeutic options before clinical conditions worsen. To date, there are no validated predictive markers of primary platinum refractory or resistant disease and traditional cancer models are currently incompatible with treatment time window in this clinical setting.\n\nAmong cancer models, ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.\n\nFor these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer;\n2. Age over 18 years;\n3. Estimated life expectancy of at least 4 weeks;\n4. Fagotti score (PIV) \\> 8 or patients not considered operable in the first place for any reasons;\n5. Histologic diagnoses of epithelial ovarian cancer at frozen section.\n\nExclusion Criteria:\n\n1. Non- epithelial histology at frozen section;\n2. Patients enrolled in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT06065358', 'acronym': 'TOSCA', 'briefTitle': 'Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction', 'orgStudyIdInfo': {'id': '4128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional, prospective, monocentric', 'interventionNames': ['Procedure: Tumor biopsy']}], 'interventions': [{'name': 'Tumor biopsy', 'type': 'PROCEDURE', 'description': "Patients with advanced suspected HGSOC will be considered eligible (FIGO stage from III C or greater). At the time of surgery, patients' disease extension will be assessed with the Fagotti score (PIV) and the Vizzielli score (VS). Only patients who are not considered operable in the first place, will be enrolled. Samples will be taken during surgery that will take place in the operating rooms of oncological gynaecology.", 'armGroupLabels': ['Interventional, prospective, monocentric']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Camilla Nero, PhD', 'role': 'CONTACT', 'email': 'camilla.nero@policlinicogemelli.it', 'phone': '0630158667'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}