Urothelial CarcinomaNCT05945108
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
An observational study of Urothelial Carcinoma and Non Muscle Invasive Bladder Cancer, run by AstraZeneca at 5 sites in Brazil.
Trial summary
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer, Muscle-invasive Bladder Cancer
- How many people
- 400 participants
- Where
- 5 sitesBrazil
- Study dates
- 10 Jul 2023to 18 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects to be enrolled are those with early urothelial carcinoma (high-risk non-muscle invasive and localized muscle-invasive), who meet the eligibility criteria and have been treated and followed in study participating sites within the last 6 years (period from 2017 to 2022).
Who may be able to join
- Age ≥ 18 years old;
- Diagnosis of high-risk non-muscle invasive urothelial carcinoma, defined as:
- T1 tumor and/or high-grade lesion (G3) and/or presence of CIS.
- Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm);
- Diagnosis of early muscle-invasive urothelial bladder carcinoma (cT2, cT3 or cT4a N0);
- Consent to participate in the study.
Who cannot join
- Low-risk non-muscle invasive urothelial carcinoma (single lesion, pTa and low-grade);
- Locally advanced muscle-invasive urothelial carcinoma (suspected lymph node impairment in staging imaging tests) or metastatic at diagnosis;
- Bladder carcinoma with non-urothelial histology (adenocarcinoma, squamous-cell carcinoma or small cell carcinoma);
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Research Site
Belo Horizonte
Research Site
Porto Alegre
Research Site
Recife
Research Site
Salvador
Research Site
São Paulo
About this study
Official title: Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER: Multicenter Retrospective Study (Real World Evidence - RWE)
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).
Read the detailed description
Urothelial carcinoma has several histological types, extensive genetic diversity and a wide array of risk factors related to disease development. Moreover, the treatment effectiveness may be widely impacted by factors such as age, previous comorbidities, socio-economic factors, late diagnosis and access to treatment. In the last decade, the treatment profile has evolved worldwide with the incorporation of new technologies, however, there is no data on Brazilian reality in this period. In a continent-sized country and such heterogeneous health services as Brazil, preparing such knowledge becomes more important and challenging. This paper proposed to describe early urothelial carcinoma presentation pattern and treatment in Brazilian population (high-risk non-muscle-invasive and localized muscle-invasive) in several sites spread throughout the national territory. Thus, data will be generated to provide a more appropriate understanding of the current landscape and, consequently, the better design of public policies to face this disease.
- Keywords
- Bladder Cancer, RWE
- Medical subject headings
- Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-muscle-invasive bladder cancer or Muscle-invasive bladder cancer | Defined as: * T1 tumor and/or high-grade lesion (G3) and/or presence of CIS (Carcinoma in situ). * Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm); Or: -Diagnosis of early muscle-invasive urothelial bladder carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical staging
Description of the characteristics of the lesions at the initial diagnosis, performed by histopathology and imaging exams.
Measured: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start10 Jul 2023
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein
- Responsible party
- Sponsor
- Investigators
- Fernando Maluf, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945108
- Sponsor's protocol ID
- D133HR00023
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 approved.
Publications
Castello Dias Carneiro AP, Batista EC, Gomes Bugano DD, Corradi RG, Panhoca R, Soler JA, Carvalhal E, Ponte de Souza AL, Motke B, Helber HA, Sampaio BDS, Monfardini F, Lamas Assis SR, Rodrigues Sant'Anna VA, Prado Dos Santos G, Lopes da Silva M, Duarte FM, Pereira M, Fagundes Moia DD, Soares RVP, Carneiro A, Perini GF, Rizzo LV, Maluf FC. Treatment Patterns and Outcomes in Localized Urothelial Carcinoma in Middle-Income Countries: A Multicenter Real-World Study. JCO Glob Oncol. 2026 Apr;12(4):e2500324. doi: 10.1200/GO-25-00324. Epub 2026 Apr 29.
PubMed 42054609
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER: Multicenter Retrospective Study (Real World Evidence - RWE)
- ClinicalTrials.gov ID
- NCT05945108
- Acronym / sponsor ID
- D133HR00023
- Keywords
- Bladder Cancer, RWE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).
Detailed description
Urothelial carcinoma has several histological types, extensive genetic diversity and a wide array of risk factors related to disease development. Moreover, the treatment effectiveness may be widely impacted by factors such as age, previous comorbidities, socio-economic factors, late diagnosis and access to treatment. In the last decade, the treatment profile has evolved worldwide with the incorporation of new technologies, however, there is no data on Brazilian reality in this period. In a continent-sized country and such heterogeneous health services as Brazil, preparing such knowledge becomes more important and challenging. This paper proposed to describe early urothelial carcinoma presentation pattern and treatment in Brazilian population (high-risk non-muscle-invasive and localized muscle-invasive) in several sites spread throughout the national territory. Thus, data will be generated to provide a more appropriate understanding of the current landscape and, consequently, the better design of public policies to face this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-muscle-invasive bladder cancer or Muscle-invasive bladder cancer | – | –Defined as: * T1 tumor and/or high-grade lesion (G3) and/or presence of CIS (Carcinoma in situ). * Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm); Or: -Diagnosis of early muscle-invasive urothelial bladder carcinoma. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects to be enrolled are those with early urothelial carcinoma (high-risk non-muscle invasive and localized muscle-invasive), who meet the eligibility criteria and have been treated and followed in study participating sites within the last 6 years (period from 2017 to 2022).
Key inclusion criteria (6 listed)
- Age ≥ 18 years old;
- Diagnosis of high-risk non-muscle invasive urothelial carcinoma, defined as:
- T1 tumor and/or high-grade lesion (G3) and/or presence of CIS.
- Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm);
- Diagnosis of early muscle-invasive urothelial bladder carcinoma (cT2, cT3 or cT4a N0);
Key exclusion criteria (3 listed)
- Low-risk non-muscle invasive urothelial carcinoma (single lesion, pTa and low-grade);
- Locally advanced muscle-invasive urothelial carcinoma (suspected lymph node impairment in staging imaging tests) or metastatic at diagnosis;
- Bladder carcinoma with non-urothelial histology (adenocarcinoma, squamous-cell carcinoma or small cell carcinoma);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical staging
Time frame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Description of the characteristics of the lesions at the initial diagnosis, performed by histopathology and imaging exams.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 42054609Castello Dias Carneiro AP, Batista EC, Gomes Bugano DD, Corradi RG, Panhoca R, Soler JA, Carvalhal E, Ponte de Souza AL, Motke B, Helber HA, Sampaio BDS, Monfardini F, Lamas Assis SR, Rodrigues Sant'Anna VA, Prado Dos Santos G, Lopes da Silva M, Duarte FM, Pereira M, Fagundes Moia DD, Soares RVP, Carneiro A, Perini GF, Rizzo LV, Maluf FC. Treatment Patterns and Outcomes in Localized Urothelial Carcinoma in Middle-Income Countries: A Multicenter Real-World Study. JCO Glob Oncol. 2026 Apr;12(4):e2500324. doi: 10.1200/GO-25-00324. Epub 2026 Apr 29.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: 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 approved.
Related trials for Urothelial Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Registry Platform Urologic Cancer
Renal Cell Carcinoma, Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Maluf, MD principal investigator
Hospital Israelita Albert Einstein
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Non Muscle Invasive Bladder Cancer, run by AstraZeneca at 5 sites in Brazil.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical staging (time frame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05945108, which also lists 1 linked publication.
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 11 Apr 2025.