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Treatment approaches and biomarker prevalence in bladder cancer in Russia

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

Observational AstraZeneca · NCT07038928

This project tests how common HER2 and PD-L1 markers are at different stages of bladder cancer and records current treatment approaches in adults across Russia.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations19 sites (Arkhangelsk and 18 other locations)
Trial IDNCT07038928 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with confirmed urothelial bladder cancer at high-risk NMIBC, MIBC, or metastatic stage who can give informed consent and have an available FFPE tumor sample are ideal candidates.

Not a fit: Patients currently participating in any interventional trial since their bladder cancer diagnosis, those without available tumor tissue, or those who do not meet the timing criteria for surgery/diagnosis are unlikely to receive benefit from this observational work.

Why it matters

Potential benefit: If successful, the results could help clinicians decide when to test for HER2 or PD-L1 and better tailor testing and treatment decisions for patients with bladder cancer in Russia.

How similar studies have performed: Large observational registries have characterized PD-L1 prevalence and informed testing practices, while HER2 prevalence in bladder cancer is less consistently characterized and remains more exploratory.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Arkhangelsk and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bladder Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.