Observational Study on Treatment Methods and HER2 and PD-L1 Biomarker Prevalence in Different Stages of Urothelial Bladder Cancer in Russia

What this Trial Is About

Researchers are conducting a multicenter observational study in Russia to examine treatment methods and the prevalence of HER2-positive status in various stages of bladder cancer, including PD-L1-positive status in metastatic bladder cancer. The study aims to collect and analyze epidemiologic data without changing routine clinical care. Approximately 600 adult patients with urothelial bladder cancer will be enrolled from about 30 specialized oncology centers, divided into three equal groups based on cancer stage high-risk non-muscle-invasive, muscle-invasive, and metastatic bladder cancer. Participants will be observed during a single routine clinical visit where demographic, clinical, and treatment information will be recorded. Tumor tissue samples collected during standard care will be sent to a central laboratory for testing. No interventions or additional diagnostic procedures will be performed as part of the study. Enrollment is expected to continue for about 18 months or until 600 patients have been included and all necessary data and test results are collected. Participants provide their medical data, including treatment history, during their routine visits, and tumor samples are analyzed centrally. Researchers will measure various outcomes related to treatment patterns and biomarker prevalence over a 24-month period. The study focuses on proportions of patients receiving different treatments, relapse rates, progression timelines, and biomarker status. There is no follow-up planned beyond the single visit, and safety monitoring is not part of this observational study.

TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation