Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer

NCT04726735 | Completed

• 1 other identifier: CHUBX2018/55
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC). The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy. Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes. The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC. The secondary objective is to characterize the immune contexture of NMIBC.

Conditions

Bladder Cancer

Keywords

Non Muscle Invasive Bladder Cancer; Bacillus Calmette-Guerin; Programmed cell Death-Ligand protein 1; Programmed cell Death 1; Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• PD-L1 status (positive or negative) of the tumor and tumor associated immune cells.

  PD-L1 status will be considered positive if more than 25% of tumor cells exhibit membrane staining or immune cells present (ICP) \>1% and immune cells (IC)+ \>25% or ICP=1% and IC+ = 100%. PD-L1 status will be considered negative if none of the criteria for PD-L1 positive status are met.

  Day 1

Secondary Outcomes (2)

• Descriptive analysis of the differential expression of all the following immune biomarkers in normal bladder tissue, NMIBC (Non Muscle Invasive Bladder Cancer) and MIBC (Muscle Invasive Bladder Cancer).

  Day 1

• Association of immune profile with recurrence and progression rates

  Day 1

Study Arms (3)

Patients with histologically documented normal bladder

Biological: Samples of bladder tissue

Patients with histologically documented Non Muscle Invasive Bladder Cancer

Biological: Samples of bladder tissue

Patients with histologically documented Muscle Invasive Bladder Cancer

Biological: Samples of bladder tissue

Interventions

Samples of bladder tissue BIOLOGICAL

Samples of bladder tissue collected between 2007 and 2011.

Patients with histologically documented Muscle Invasive Bladder Cancer; Patients with histologically documented Non Muscle Invasive Bladder Cancer; Patients with histologically documented normal bladder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.

You may qualify if:

• Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.
• Samples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions.

You may not qualify if:

• History of autoimmune disease
• Active tuberculosis
• Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Talence, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples taken from 2007 to 2011 and stored in the tissue bank from Bordeaux hospital

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive 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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: March 16, 2020
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)