NCT05945108|Completed
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Sponsor study identifier
observational
400
1 country
5
Study Start
July 10, 2023
Actual (reported)Primary Completion
April 18, 2024
Actual (reported)Study Completion
April 18, 2024
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 18, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2023
Actual (reported)July 10, 2023
Actual (reported)July 14, 2023
Actual (reported)April 18, 2024
Actual (reported)April 18, 2024
Actual (reported)Clinical staging
Description of the characteristics of the lesions at the initial diagnosis, performed by histopathology and imaging exams.
At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
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.
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).
Research Site
Belo Horizonte, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Recife, Brazil
Research Site
Salvador, Brazil
Research Site
São Paulo, Brazil
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.
Fernando Maluf, MD
Hospital Israelita Albert Einstein
400 participants (actual enrollment reported by the registry).
First Submitted
June 22, 2023
First Posted
July 14, 2023
Study Start
July 10, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 18, 2024
Actual (reported)Study Completion
April 18, 2024
Actual (reported)Last Updated
April 11, 2025
Record last verified: 2025-04
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.
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Source: ClinicalTrials.gov.
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