Treatment approaches and biomarker prevalence in bladder cancer in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, observational study enrolling about 600 adults with urothelial bladder cancer across roughly 30 oncology centers in the Russian Federation. Enrolled consecutive patients will be grouped into three cohorts of about 200 each by disease stage: high-risk NMIBC, MIBC, and metastatic bladder cancer. Investigators will extract primary and secondary data from medical records, enter information into an electronic case report form, and perform testing on available FFPE tumor samples; there is a single routine visit and no study-directed intervention or follow-up. Epidemiologic methods and descriptive analysis will be used to report treatment patterns and the prevalence of HER2 and PD-L1 by stage.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Arkhangelsk, Russia Recruiting
• Research Site
  Barnaul, Russia Recruiting
• Research Site
  Chelyabinsk, Russia Recruiting
• Research Site
  Krasnodar, Russia Recruiting
• Research Site
  Krasnoyarsk, Russia Recruiting
• Research Site
  Makhachkala, Russia Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.