Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06782451
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011677', 'term': 'Punctures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-07-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest.', 'timeFrame': '1 month', 'description': 'The primary evaluation criterion is the percentage of patients for whom viable spheroids were obtained from tumors with a molecular abnormality of interest, measured by cell viability one month after the tumor sample was collected.'}], 'secondaryOutcomes': [{'measure': 'Obtain spheroids that are phenotypically and genotypically stable.', 'timeFrame': '1 month', 'description': 'The phenotypic and genotypic stability of spheroids over time will be assessed using molecular characterization techniques (e.g., immunohistochemistry, sequencing).'}, {'measure': 'Validate preclinical models to study the tumor response to innovative therapies.', 'timeFrame': '1 month', 'description': 'The ability of spheroids to mimic aspects of the tumor microenvironment, such as hypoxia and extracellular matrix formation, will be evaluated.'}, {'measure': 'Test the efficacy of molecules targeting variations identified in these tumors.', 'timeFrame': '1 month', 'description': 'The response of the spheroids to specific anti-tumor therapies will be evaluated through drug sensitivity tests (e.g., cytotoxicity assays).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spheroids', 'Preclinic models'], 'conditions': ['Neoplasm Malignant']}, 'descriptionModule': {'briefSummary': 'This study aims to collect tumor samples from patients carrying a mutation of interest to develop a cell culture technique for "spheroids.\n\nThe goal is to use these spheroids to model responses to anticancer treatments. Various therapeutic molecules can be tested on these spheroids, enabling the evaluation of the potential of new molecules or the activity of existing ones specifically on the tumor (bearing the mutation of interest) from which the spheroid was developed.\n\nTumor samples will be collected as part of biopsies or surgeries conducted during routine patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older.\n* Patient for whom at least one mutation deemed of interest by the investigator has been identified.\n* Patient with a malignant tumor at a locally advanced or metastatic stage, for whom a tissue tumor sample (via surgery, radiology, or endoscopy) is scheduled as part of their standard care.\n* Tumor volume deemed sufficient by the physician to ensure an adequate amount of material for analysis by the pathologist and the transfer of a part of the tumor sample to the Laboratory of Translational Research in Oncology for the study.\n* INR \\< 1.5; Platelets \\> 50,000/μL.\n* Patient who has been informed of the study and has signed the informed consent form.\n* Patient affiliated with a social security insurance.\n\nExclusion Criteria:\n\n* Patient with multiple primary malignant tumors.\n* Patient with a known HIV, Hepatitis C, or Hepatitis B infection.\n* Patient on:\n\n * Clopidogrel (hydrogensulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) with no possibility of suspension for 5 days,\n * Low molecular weight heparin with no possibility of dose suspension before the procedure,\n * Fondaparinux with no possibility of suspension,\n * Abciximab with no possibility of suspension for 24 hours and aPTT \\< 50s and ACT \\< 150s,\n * Eptifibatide or Tirofiban Hydrochloride Monohydrate or Argatroban with no possibility of suspension 4 hours before the procedure,\n * Bivalirudin with no possibility of suspension 2-3 hours if CrCL \\>50 mL/min or 3-5 hours if CrCL \\<50 mL/min before the procedure,\n * Dabigatran etexilate with no possibility of suspension 2-3 days if CrCL \\>50 mL/min or 3-5 days if CrCL \\<50 mL/min before the procedure.\n* Patient considered vulnerable; vulnerable persons are defined in articles L1121-5 to L1121-8:\n\n * Pregnant women, parturients, and breastfeeding mothers,\n * Individuals deprived of their liberty by a judicial or administrative decision, individuals hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and individuals admitted to a healthcare or social facility for reasons other than research,\n * Adults under legal protection or unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT06782451', 'acronym': 'DST', 'briefTitle': 'Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Antoine Lacassagne'}, 'officialTitle': 'Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.', 'orgStudyIdInfo': {'id': '2023/57'}, 'secondaryIdInfos': [{'id': '2024-A01616-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'For this study, the included patients will have a biopsy or a surgery performed as part of routine patient care. A part of the tumor sample will be transmitted to the Laboratory of Translational Research in Oncology to develop spheroids.\n\nA blood sample will also be taken (38 mL) and analyzed by the Laboratory of Translational Research in Oncology in order to assess hematological toxicities of drugs and study a potential link between disease stage and the quantity of exosomes secreted.', 'interventionNames': ['Procedure: Surgery or biopsy', 'Procedure: Blood sample']}], 'interventions': [{'name': 'Surgery or biopsy', 'type': 'PROCEDURE', 'description': 'A part of the tumor sample collected during the surgery or the biopsy performed as part of routine patient care will be used for the research.', 'armGroupLabels': ['Experimental']}, {'name': 'Blood sample', 'type': 'PROCEDURE', 'description': '38 mL of blood will be taken for the study.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06189', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Study coordinator', 'role': 'CONTACT', 'email': 'DRCI-Promotion@nice.unicancer.fr'}, {'name': 'Esma SAADA-BOUZID', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Study coordinator', 'role': 'CONTACT', 'email': 'DRCI-Promotion@nice.unicancer.fr', 'phone': '+33 04 92 03 14 76', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Antoine Lacassagne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}