Antitumor T Cell Responses in Patients With Bladder Cancer (immunoBLAD)

Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Biological samples

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Jihane Boustani, MD, PhD; Phone Number: +33 3 70 63 23 02; Email: jboustani@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients treated for a bladder cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients treated with intravesical instillations for non-invasive bladder cancer	Other: Biological samples; Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort. Tumor tissues will be collected at baseline for three patients.
Cohort B; Patients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer	Other: Biological samples; Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort. Tumor tissues will be collected at baseline for three patients.
Cohort C; Patients treated with neo-adjuvant chemotherapy for invasive bladder cancer	Other: Biological samples; Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort. Tumor tissues will be collected at baseline for three patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor antigen specific T-cell responses	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.	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)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2024
• Primary Completion (Estimated): April 2, 2026
• Study Completion (Estimated): April 2, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 098 DRC 210 ER03 012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No