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 range18 Years

SexALL

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.

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

Timeframe: 24 months

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 range18 Years

SexALL

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

Timeframe: 24 months