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)

Research Site

Arkhangelsk, Russia

Research Site

Barnaul, Russia

Research Site

Chelyabinsk, Russia

Research Site

Krasnodar, Russia

Research Site

Krasnoyarsk, Russia

Research Site

Makhachkala, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Nizhny Novgorod, Russia

Research Site

Novosibirsk, Russia

Research Site

Obninsk, Russia

Research Site

Omsk, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saint Petersburg, Russia

Research Site

Tomsk, Russia

Research Site

Tyumen, Russia

Research Site

Ufa, Russia

Research Site

Ufa, Russia

Research Site

Yekaterinburg, Russia

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NCT07038928


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