Antitumor T Cell Responses in Patients With Bladder Cancer

NCT06334406 | Not Yet Recruiting

• 1 other identifier: 098 DRC 210 ER03 012
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• Overall survival

  Date of death from any cause (within 2 years after the initiation of the treatment)

• Progression-free survival

  date of first progression of the disease (within 2 year after the initiation of the treatment)

Study Arms (3)

Cohort A

Patients treated with intravesical instillations for non-invasive bladder cancer

Other: Biological samples

Cohort B

Patients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer

Other: Biological samples

Cohort C

Patients treated with neo-adjuvant chemotherapy for invasive bladder cancer

Other: Biological samples

Interventions

Biological samples OTHER

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 A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated for a bladder cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Jihane Boustani, MD, PhD

CONTACT

+33 3 70 63 23 02; jboustani@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 28, 2024
• Study Start: April 2, 2024
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-03