Looks at treatments and HER2 and PD-L1 markers in bladder cancer
Observes how bladder cancer patients are treated and how often markers are present.
Key facts
- Who runs it
- AstraZeneca
- Where
- Arkhangelsk, Barnaul, Chelyabinsk, Krasnodar, Krasnoyarsk, Makhachkala, Moscow, Nizhny Novgorod, Novosibirsk, Obninsk, Omsk, Saint Petersburg, Tomsk, Tyumen, Ufa, and Yekaterinburg, RussiaSee the 16 sites
- Trial code
- Registry title
- TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 30 Jun 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Observational, 3 groups
- Record updated
- 14 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with urothelial bladder cancer at an early, muscle-invasive or metastatic stage. A stored tumour tissue sample must be available.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed urothelial bladder cancer: non-muscle-invasive (NMIBC) with at least 1 high-risk feature, muscle-invasive (MIBC) after cystectomy, or metastatic (mBC) diagnosed in the last 12 months.
- Earlier treatment
- NMIBC: TURBT done at least 1 month but not more than 12 months before entry. MIBC: cystectomy done at least 2 months but not more than 12 months before entry.
- Biomarker or test result
- A tumour tissue sample (FFPE) from a biopsy or surgery must be available for testing. The study looks at HER2 and PD-L1 status.
Main reasons for not taking part
- Took part in any interventional trial since the bladder cancer diagnosis
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participation in any interventional trial since the urothelial bladder cancer diagnosis
Where in Russia
- ArkhangelskHospital not named in the registryTaking people
- BarnaulHospital not named in the registryTaking people
- ChelyabinskHospital not named in the registryTaking people
- KrasnodarHospital not named in the registryTaking people
- KrasnoyarskHospital not named in the registryTaking people
- MakhachkalaHospital not named in the registryTaking people
- MoscowHospital not named in the registryTaking people
- Nizhny NovgorodHospital not named in the registryTaking people
- NovosibirskHospital not named in the registryNo longer taking part
- ObninskHospital not named in the registryNot yet recruiting
- OmskHospital not named in the registryTaking people
- Saint PetersburgHospital not named in the registryTaking people
- TomskHospital not named in the registryTaking people
- TyumenHospital not named in the registryTaking people
- UfaHospital not named in the registryTaking people
- YekaterinburgHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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
The 3 groups in the trial
- Patients with NMIBC
Non-muscle-invasive bladder cancer
- Patients with MIBC
Muscle-invasive bladder cancer
- Patients with mBC
Metastatic bladder cancer
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Looks at treatments and HER2 and PD-L1 markers in bladder cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 14 September 2026