An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients. — POLARIS  

Urinary Bladder Cancer Clinical Trial

Official title: An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation of Initial Treatment Pattern and Overall Survival in the Chinese Muscle Invasive Urothelial Bladder Carcinoma Patients.

Status Completed

Clinical Trial Summary

The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.

Clinical Trial Description

The primary objective of this observational study is: •To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control. Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High. The second objectives of this observational study are: - To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients. - To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab. - To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China. - To observe 2-year OS of the Chinese MIUBC patients. The exploratory objectives of this observational study are: - To explore the relationship between the demographic characteristics and expression of PD-L1 and other exploratory biomarkers including immune cell (IC) subset CD8+ T cells and tumor mutation burden (TMB). - To explore the relationship between OS and the demographic characteristics as well as the expression of biomarkers. - To explore the relationship between PD-L1 and TMB, PD-L1 and CD8 positive T cell respectively. ;

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT03433924
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Start date: May 18, 2020
• Completion date: March 27, 2023