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Bladder CancerRIVERSNCT07038928

TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation

An observational study of Bladder Cancer, run by AstraZeneca at 20 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
How many people
600 participants
Where
20 sitesRussia
Study dates
30 Jun 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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 join

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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

20 sites in 1 country

Russia20 sites, 17 recruiting
  • Research Site

    Arkhangelsk

    Recruiting
  • Research Site

    Barnaul

    Recruiting
  • Research Site

    Chelyabinsk

    Recruiting
  • Research Site

    Krasnodar

    Recruiting
  • Research Site

    Krasnoyarsk

    Recruiting
  • Research Site

    Makhachkala

    Recruiting
  • Research Site

    Moscow

    Recruiting
  • Research Site

    Moscow

    Withdrawn
  • Research Site

    Moscow

    Not yet recruiting
  • Research Site

    Nizhny Novgorod

    Recruiting
  • Research Site

    Novosibirsk

    Withdrawn
  • Research Site

    Obninsk

    Not yet recruiting
  • Research Site

    Omsk

    Recruiting
  • Research Site

    Saint Petersburg

    Recruiting
  • Research Site

    Saint Petersburg

    Not yet recruiting
  • Research Site

    Saint Petersburg

    Withdrawn
  • Research Site

    Tomsk

    Recruiting
  • Research Site

    Tyumen

    Recruiting
  • Research Site

    Ufa

    Recruiting
  • Research Site

    Yekaterinburg

    Recruiting

Other trials in Russia

About this study

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

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

Read the detailed description

This is an observational study entailing primary and secondary data collection. As an observational, this study does not imply any intervention into a routine clinical practice, including choice of treatment modality or additional diagnostic methods. Epidemiologic methods and descriptive analysis will be used for data collection and evaluation of all endpoints and measurements of interest.

It will be a multicentre study. Planned number of study sites is about 30 oncological centres performing specialised treatment and follow-up of patients with urothelial bladder cancer in different regions of Russia. 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.

The investigator will enter medical data of the enrolled patients into the electronic case report form (eCRF) from the source medical documentation. No follow-up is planned, the study will consist of only one visit carried out according to routine clinical practice, where patient's demographic and clinical characteristics as well as medical history and used treatment approaches will be recorded, and formalin-fixed paraffin-embedded (FFPE) tumour tissue samples collected as part of routine clinical practice will be shipped to the central laboratory.

The overall expected duration of the study enrollment is about 18 months or until 600 patients will be included in the study, and all required data (including results of IHC testing in central laboratory) will be collected, whichever occurs first.

Conditions
Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07038928
Study groupRoleWhat they receive
Patients with NMIBCNon-muscle-invasive bladder cancer
Patients with MIBCMuscle-invasive bladder cancer
Patients with mBCMetastatic bladder cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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);

    Measured: 24 months

  2. 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);

    Measured: 24 months

  3. 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);

    Measured: 24 months

  4. 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);

    Measured: 24 months

  5. 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);

    Measured: 24 months

  6. 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);

    Measured: 24 months

  7. 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)

    Measured: 24 months

  8. 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))

    Measured: 24 months

  9. 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))

    Measured: 24 months

  10. Time to first relapse of NMIBC

    Time to first relapse of NMIBC (ongoing and anamnestic)

    Measured: 24 months

  11. 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);

    Measured: 24 months

  12. 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);

    Measured: 24 months

  13. 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.

    Measured: 24 months

  14. 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);

    Measured: 24 months

  15. 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);

    Measured: 24 months

  16. 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;

    Measured: 24 months

  17. 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);

    Measured: 24 months

  18. Proportion of patients with locoregional progression after cystectomy

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

    Measured: 24 months

  19. 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);

    Measured: 24 months

  20. 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.

    Measured: 24 months

Secondary outcomes (5)
  1. Prevalence of IHC-defined HER2-positive status among patients with high-risk NMIBC

    Prevalence of immunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumor tissue samples) among patients with high-risk Non-muscle-invasive bladder cancer;

    Measured: 24 months

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

    Prevalence of mmunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumour tissue samples) among patients with Muscle-invasive bladder cancer;

    Measured: 24 months

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

    Prevalence of mmunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumour tissue samples) among patients with mBC;

    Measured: 24 months

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

    Concordance of immunohistochemically-defined HER2-positive status (defined as proportion of patients with 3+ HER2 protein expression based on immunohistochemistry testing of formalin-fixed paraffin-embedded tumour tissue samples) among patients with Non-muscle-invasive bladder cancer, muscle-invasive bladder cancer and metastatic bladder cancer in primary tumor samples and metastasis if both available;

    Measured: 24 months

  5. Prevalence of PD-L1 positive status among patients with mBC

    Prevalence of PD-L1 positive status (defined as proportion of patients with at least one of the following criteria based on IHC testing of Formalin-fixed paraffin-embedded tumour tissue sample: (1) ≥25% PD L1 positive tumor cells; (2) ≥25% PD-L1-positive immune cells if >1% of the tumor area contained such cellular elements; or (3) 100% PD-L1-positive immune cells if 1% of the tumor area contained immune cells) among patients with metastatic bladder cancer.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start30 Jun 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07038928
Sponsor's protocol ID
D133HR00057
Acronym
RIVERS
Status last verified
Sep 2026
First submitted
5 Jun 2025
Last updated
14 Sep 2026
Results posted
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by AstraZeneca at 20 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients receiving any intravesical treatment among patients with high-risk NMIBC (time frame: 24 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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