Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 4:59 AM
Study NCT ID:
NCT06334406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antitumor T Cell Responses in Patients With Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-04-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor antigen specific T-cell responses', 'timeFrame': '15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)', 'description': 'Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-γ method, compared to the measurement at baseline.'}], 'secondaryOutcomes': [{'measure': 'Monitoring of T cells in the blood', 'timeFrame': '15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)', 'description': 'Flow cytometry analysis using T cell markers for : activation (ICOS, CD137, OX40), differenciation (CD45RA, CCR7, CD62L, CD95), cytotoxicity (perforin, granzyme B, GNLY, SlamF7) and exhaustion (PD-1, TIM-3, TIGIT, TCF1, CD39)'}, {'measure': 'Monitoring of immune cell death parameters in the blood', 'timeFrame': '15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)', 'description': 'ATP and HMGB1 by ELISA test'}, {'measure': 'Monitoring of immune suppressive cells in the blood', 'timeFrame': '15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)', 'description': 'Flow cytometry analysis using Treg markers (CD3, CD4, CD25, CD127, Foxp3) and monocytic MDSC (CD14, CD11b, CD33, HLA-DR, and lineage cocktail CD3 CD19 CD56).'}, {'measure': 'Overall survival', 'timeFrame': 'Date of death from any cause (within 2 years after the initiation of the treatment)', 'description': 'Time between the date of diagnosis and the date of death from any cause'}, {'measure': 'Progression-free survival', 'timeFrame': 'date of first progression of the disease (within 2 year after the initiation of the treatment)', 'description': 'Time interval between the date of diagnosis and the date of first progression (local, pelvic, metastatic \\[extent of the disease by RECIST v1.1\\]) or death from any cause'}, {'measure': 'Local progression-free survival', 'timeFrame': 'date of first local progression of the disease (within 2 year after the initiation of the treatment)', 'description': 'Time interval between the date of diagnosis and the date of first local progression or death from any cause'}, {'measure': 'Transcriptomic analysis', 'timeFrame': 'At baseline', 'description': 'Expression of genes of the anti-tumor responses in blood and tumor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for a bladder cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor\n* For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)\n* Written informed consent\n\nExclusion Criteria:\n\n* History of TURBT for a bladder tumor whatever the stage\n* Stages N1-3 or M1 on initial assessment\n* Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)\n* History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer\n* HIV, hepatitis C or B infection\n* Patients with any medical or psychiatric condition or disease,\n* Patients under guardianship, curatorship or under the protection of justice.'}, 'identificationModule': {'nctId': 'NCT06334406', 'acronym': 'immunoBLAD', 'briefTitle': 'Antitumor T Cell Responses in Patients With Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer', 'orgStudyIdInfo': {'id': '098 DRC 210 ER03 012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Patients treated with intravesical instillations for non-invasive bladder cancer', 'interventionNames': ['Other: Biological samples']}, {'label': 'Cohort B', 'description': 'Patients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer', 'interventionNames': ['Other: Biological samples']}, {'label': 'Cohort C', 'description': 'Patients treated with neo-adjuvant chemotherapy for invasive bladder cancer', 'interventionNames': ['Other: Biological samples']}], 'interventions': [{'name': 'Biological samples', 'type': 'OTHER', 'description': 'Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort.\n\nTumor tissues will be collected at baseline for three patients.', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jihane Boustani, MD, PhD', 'role': 'CONTACT', 'email': 'jboustani@chu-besancon.fr', 'phone': '+33 3 70 63 23 02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}