TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

NCT07038928 | Recruiting

• 1 other identifier: D133HR00057
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (20)

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

  Proportion of patients receiving any intravesical treatment among patients with high-risk Non-muscle invasive bladder cancer (ongoing and anamnestic);

  24 months

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

  Proportion of patients receiving intravesical chemotherapy among patients with high-risk ongoing and anamnestic Non-muscle invasive bladder cancer (overall and by each treatment regimen);

  24 months

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

  Proportion of patients receiving intravesical Bacillus Calmette-Guérin treatment among patients with high-risk ongoing and anamnestic Non-muscle-invasive bladder cancer (overall and by each treatment regimen: induction/ induction + maintenance);

  24 months

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

  Proportion of patients receiving any intravesical treatment among patients with non-high-risk Non-muscle-invasive bladder cancer (anamnestic);

  24 months

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

  Proportion of patients receiving intravesical chemotherapy among patients with non-high-risk anamnestic Non-muscle-invasive bladder cancer (overall and by each treatment regimen);

  24 months

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

  Proportion of patients receiving intravesical Bacillus Calmette-Guérin treatment among patients with non high-risk anamnestic Non-muscle-invasive bladder cancer(overall and by each treatment regimen: induction/ induction + maintenance);

  24 months

• Proportion of patients without intravesical NMIBC treatment

  Proportion of patients without intravesical Non-muscle-invasive bladder cancer (ongoing and anamnestic) treatment (high-risk, non-high-risk)

  24 months

• Number of relapses in high risk NMIBC patients (ongoing and anamnestic) overall and by each treatment regimen

  Number of relapses in high risk Non-muscle-invasive bladder cancer patients (ongoing and anamnestic) overall and by each treatment regimen (intravesical chemotherapy, intravesical BCG (induction or induction with maintenance))

  24 months

• Number of relapses in non-high risk NMIBC patients overall and by each treatment regimen, intravesical BCG

  Number of relapses in non-high risk Non-muscle-invasive bladder cancer patients (anamnestic) overall and by each treatment regimen (intravesical chemotherapy, intravesical Bacillus Calmette-Guérin (induction or induction with maintenance))

  24 months

• Time to first relapse of NMIBC

  Time to first relapse of NMIBC (ongoing and anamnestic)

  24 months

• Proportion of patients receiving neoadjuvant treatment among patients with MIBC

  Proportion of patients receiving neoadjuvant treatment among patients with Muscle-invasive bladder cancer (ongoing and anamnestic) (overall and by each treatment regimen);

  24 months

• Rate of pathologic complete response among MIBC patients receiving neoadjuvant treatment

  Rate of pathologic complete response among Muscle-invasive bladder cancer patients (ongoing and anamnestic) receiving neoadjuvant treatment (overall and by each treatment regimen);

  24 months

• Proportion of MIBC patients not received neoadjuvant treatment before radical cystectomy

  Proportion of Muscle-invasive bladder cancer patients (ongoing and anamnestic) not received neoadjuvant treatment before radical cystectomy.

  24 months

• Proportion of patients received adjuvant treatment among patients with MIBC

  Proportion of patients received adjuvant treatment among patients with Muscle-invasive bladder cancer (ongoing and anamnestic) (overall and by each treatment regimen);

  24 months

• Proportion of MIBC patients (anamnestic) received trimodal therapy

  Proportion of Muscle-invasive bladder cancer patients (anamnestic) received trimodal therapy (maximal Transurethral resection of bladder tumor + chemoradiation therapy);

  24 months

• Time to progression to mBC from NMIBC and MIBC

  Time to progression to metastatic bladder cancer (anamnestic) from Non-muscle-invasive bladder cancer and Muscle-invasive bladder cancer;

  24 months

• Type of progression to mBC from NMIBC and MIBC

  Type of progression to Metastatic bladder cancer (anamnestic) from Non-muscle-invasive bladder cancer and Muscle-invasive bladder cancer(localization of metastases);

  24 months

• Proportion of patients with locoregional progression after cystectomy

  Proportion of patients with locoregional progression after cystectomy (Muscle-invasive bladder cancer, anamnestic);

  24 months

• Proportions of patients receiving systemic treatment regimens within first-line therapy among patients with mBC

  Proportions of patients receiving systemic treatment regimens within first-line therapy among patients with Metastatic bladder cancer (by each treatment regimen);

  24 months

• Proportion of patients with progression on first line mBC treatment

  Proportion of patients with progression on first line Metastatic bladder cancer treatment overall and by each treatment regimen.

  24 months

Secondary Outcomes (5)

• Prevalence of IHC-defined HER2-positive status among patients with high-risk NMIBC

  24 months

• Prevalence of IHC-defined HER2-positive status among patients with MIBC

  24 months

• Prevalence of IHC-defined HER2-positive status among patients with mBC;

  24 months

• Concordance of immunohistochemically-defined HER2-positive status among 3 patient cohorts

  24 months

• Prevalence of PD-L1 positive status among patients with mBC

  24 months

Study Arms (3)

Patients with NMIBC

Non-muscle-invasive bladder cancer

Patients with MIBC

Muscle-invasive bladder cancer

Patients with mBC

Metastatic bladder cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Planned study population consists of approximately 600 adult patients with urothelial bladder cancer. Patients who were diagnosed with urothelial bladder cancer and satisfy the additional eligibility criteria as assessed by the investigator will be invited to participate during routine clinical visit. Only patients who will give their written informed consent will be included. Consecutive patients included in the study will form three study cohorts of equal size (around 200 participants each) according to the stages of urothelial bladder cancer at the time of study inclusion: high-risk NMIBC, MIBC, and mBC.

You may qualify if:

• 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.

You may not qualify if:

• Participation in any interventional trial since the urothelial bladder cancer diagnosis.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (19)

Research Site

Arkhangelsk, Russia

RECRUITING

Research Site

Barnaul, Russia

RECRUITING

Research Site

Chelyabinsk, Russia

RECRUITING

Research Site

Krasnodar, Russia

NOT YET RECRUITING

Research Site

Krasnoyarsk, Russia

RECRUITING

Research Site

Makhachkala, Russia

NOT YET RECRUITING

Research Site

Moscow, Russia

NOT YET RECRUITING

Research Site

Moscow, Russia

RECRUITING

Research Site

Nizhny Novgorod, Russia

NOT YET RECRUITING

Research Site

Novosibirsk, Russia

NOT YET RECRUITING

Research Site

Obninsk, Russia

NOT YET RECRUITING

Research Site

Omsk, Russia

RECRUITING

Research Site

Saint Petersburg, Russia

RECRUITING

Research Site

Saint Petersburg, Russia

NOT YET RECRUITING

Research Site

Tomsk, Russia

NOT YET RECRUITING

Research Site

Tyumen, Russia

RECRUITING

Research Site

Ufa, Russia

RECRUITING

Research Site

Ufa, Russia

NOT YET RECRUITING

Research Site

Yekaterinburg, Russia

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 26, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (19)