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TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

RECRUITINGSponsored by AstraZeneca
Actively Recruiting
SponsorAstraZeneca
Started2025-06-30
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Bladder CancerCancer

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