NCT03433924

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

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
• Phase: —
• Study type: Observational
• Enrollment: 248 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Urinary Bladder Cancer

Timeline

• Start date: 2020-05-18
• Primary completion: 2023-03-27
• Completion: 2023-03-27
• First posted: 2018-02-15
• Last updated: 2024-03-27

Locations

17 sites across 1 country: China