A Multicentre Observational Study on Treatment Approaches and HER2 Positive Status Prevalence in Different Stages of Bladder Cancer and PD-L1-positive Status in Metastatic Bladder Cancer in Russian Federation
A multicentre observational study on treatment approaches and HER2 positive status prevalence in different stages of bladder cancer and PD-L1-positive status in metastatic bladder cancer in Russian Federation
• 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.