RecruitingNCT07038928
TReatment Approaches and bIomarkers preValence in 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
Sponsor
AstraZeneca
Enrollment
600 participants
Start Date
Jun 30, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 Years
Inclusion Criteria12
- 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 Criteria1
- • Participation in any interventional trial since the urothelial bladder cancer diagnosis.
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07038928
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