Antitumor T Cell Responses in Patients With Bladder Cancer

Not yet recruiting

• Conditions: Bladder Cancer
• Interventions: Other: Biological samples

• Registration Number: NCT06334406
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Study Start: 2024-04-02
• Primary Completion: 2026-04-02
• Study Completion: 2026-04-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• 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
• For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
• Written informed consent

Exclusion Criteria

• History of TURBT for a bladder tumor whatever the stage
• Stages N1-3 or M1 on initial assessment
• Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
• History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
• HIV, hepatitis C or B infection
• Patients with any medical or psychiatric condition or disease,
• Patients under guardianship, curatorship or under the protection of justice.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort C	Biological samples	Patients treated with neo-adjuvant chemotherapy for invasive bladder cancer
Cohort A	Biological samples	Patients treated with intravesical instillations for non-invasive bladder cancer
Cohort B	Biological samples	Patients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer

Primary Outcome Measures

Name	Time	Method
Tumor antigen specific T-cell responses	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)	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.

Secondary Outcome Measures

Name	Time	Method
Monitoring of immune cell death parameters in the blood	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)	ATP and HMGB1 by ELISA test
Transcriptomic analysis	At baseline	Expression of genes of the anti-tumor responses in blood and tumor
Monitoring of T cells in the blood	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)	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)
Local progression-free survival	date of first local progression of the disease (within 2 year after the initiation of the treatment)	Time interval between the date of diagnosis and the date of first local progression or death from any cause
Monitoring of immune suppressive cells in the blood	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)	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).
Progression-free survival	date of first progression of the disease (within 2 year after the initiation of the treatment)	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
Overall survival	Date of death from any cause (within 2 years after the initiation of the treatment)	Time between the date of diagnosis and the date of death from any cause