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Recruiting
NCT07038928
TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation
Conditions: Bladder Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 600
Sponsor: AstraZeneca
Location: Research Site Arkhangelsk
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 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.
Source: ClinicalTrials.gov (NCT07038928). StuddyBuddy aggregates publicly available trial information.