TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

Launched by ASTRAZENECA · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is a research study being done in several centers across Russia to learn more about bladder cancer. Specifically, it looks at how patients with different stages of bladder cancer are treated and how common certain markers, called HER2 and PD-L1, are in their tumors. These markers can help doctors understand the cancer better and may guide future treatments. The study is currently not recruiting participants yet.

Adults aged 18 and older who have been diagnosed with bladder cancer at various stages—early (non-muscle invasive), muscle-invasive, or metastatic (cancer that has spread)—may be eligible to join. To participate, patients need to have had specific procedures done recently, like tumor removal or bladder surgery, and must agree to provide a sample of their tumor tissue for testing. People who have joined other treatment trials since their diagnosis cannot join this study. Participants won’t receive any new treatments as part of this study; instead, doctors will collect and review existing medical information and tissue samples to better understand the disease and its characteristics. This information could help improve bladder cancer care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years;
• • Signed ICF, including consent for FFPE tumor tissue sample testing;
• • Confirmed diagnosis of urothelial bladder cancer at NMIBC, MIBC, or mBC stage at study entry;
• * For patients with NMIBC: 1. TURBT performed at least 1 month but not more than 12 months prior to study entry; 2. Presence of ≥1 high-risk feature:
• • T1 tumor
• • High grade/G3 tumor
• • CIS (carcinoma in situ)
• • Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point);
• • For patients with MIBC: Сystectomy performed at least 2 months but not more than 12 months prior to study entry;
• • For patients with mBC: mBC diagnosed during 12 months prior to study entry;
• • Availability of medical history data;
• • Availability of FFPE tumour tissue sample obtained during biopsy and/or surgery.
• Exclusion Criteria:
• • • Participation in any interventional trial since the urothelial bladder cancer diagnosis.