RecruitingNot Applicable

TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

Russia600 participantsStarted 2025-06-30

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients receiving any intravesical treatment among patients with high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical chemotherapy among patients with high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical BCG treatment among patients with high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving any intravesical treatment among patients with non-high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical chemotherapy among patients with non-high-risk anamnestic NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical BCG treatment among patients with non high-risk anamnestic NMIBC

Timeframe: 24 months

Proportion of patients without intravesical NMIBC treatment

Trial details

NCT IDNCT07038928

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Bladder Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of patients receiving any intravesical treatment among patients with high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical chemotherapy among patients with high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical BCG treatment among patients with high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving any intravesical treatment among patients with non-high-risk NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical chemotherapy among patients with non-high-risk anamnestic NMIBC

Timeframe: 24 months

Proportion of patients receiving intravesical BCG treatment among patients with non high-risk anamnestic NMIBC

Timeframe: 24 months

Proportion of patients without intravesical NMIBC treatment