Bladder Cancer Clinical Trial
— IMMUN VESSIEOfficial title:
Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
NCT number | NCT04726735 |
Other study ID # | CHUBX2018/55 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 16, 2020 |
Est. completion date | May 14, 2020 |
Verified date | January 2021 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 14, 2020 |
Est. primary completion date | May 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Talence |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Université de Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | Descriptive statistics will be performed from clinical characteristics as mean values for categorical variables, or medians (range) for non-normal continuous variables. | Day 1 | |
Secondary | Association of immune profile with recurrence and progression rates | Association between all variables will be analysed with t-test, Mann Whitney or ANOVA multiple comparison test. Correlation analysis will be performed with ?2 and Fischer exact test. Results will be considered significant if the p-value is <0.05. | Day 1 |
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