An observational study in Bladder Cancer, sponsored by AstraZeneca. Recruiting at 20 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by AstraZeneca · Observational
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Among 20 studies in Urinary Bladder Neoplasms by AstraZeneca — 5 open to participants now, 11 under way, 4 of them phase 3. Urinary Bladder Neoplasms · AstraZeneca.
Among the 20 studies in Urinary Bladder Neoplasms by AstraZeneca, this one is one of 4 that started in 2025, is one of 6 observational ones, reaches primary completion later than 5 of the 10 other live ones, and was the 17th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →5 of the 20 studies in Urinary Bladder Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Australia, Brazil and 13 more countries
Ages 18+
AstraZeneca · Sites in United States
Ages 18–130
AstraZeneca · Sites in Australia, Brazil, Canada and 4 more countries
Ages 18+
AstraZeneca
Ages 18+
By country, each count listing its studies:
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 4 · Phase 4 1
First in 2003; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 200 across 412 observational studies indexed under Urinary Bladder Neoplasms.
Median enrollment 138 across the 14 interventional studies, 324 across the 6 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
2 of the studies in Urinary Bladder Neoplasms by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07038928AstraZenecaTReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation | 2026-12-31 |
| NCT04644068AstraZenecaStudy of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | 2027-05-28 |
Add all 2 to your calendar (.ics) → With an account.
Among the 20 studies in Urinary Bladder Neoplasms by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-muscle-invasive bladder cancer
Muscle-invasive bladder cancer
Metastatic bladder cancer
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);
Time frame: 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);
Time frame: 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);
Time frame: 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);
Time frame: 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);
Time frame: 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);
Time frame: 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)
Time frame: 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))
Time frame: 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))
Time frame: 24 months
Time to first relapse of NMIBC
Time to first relapse of NMIBC (ongoing and anamnestic)
Time frame: 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);
Time frame: 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);
Time frame: 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.
Time frame: 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);
Time frame: 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);
Time frame: 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;
Time frame: 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);
Time frame: 24 months
Proportion of patients with locoregional progression after cystectomy
Proportion of patients with locoregional progression after cystectomy (Muscle-invasive bladder cancer, anamnestic);
Time frame: 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);
Time frame: 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.
Time frame: 24 months
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;
Time frame: 24 months
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;
Time frame: 24 months
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;
Time frame: 24 months
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;
Time frame: 24 months
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.
Time frame: 24 months
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: 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
Supporting information: Clinical study report
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 203 observational studies under Urinary Bladder Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 33. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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