Clinical trial NCT05945108: Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
Official title: Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER: Multicenter Retrospective Study (Real World Evidence - RWE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Non Muscle Invasive Bladder Cancer
Muscle-invasive Bladder Cancer
Keywords: Bladder Cancer, RWE
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Hospital Israelita Albert Einstein
First posted: 2023-07-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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);

Primary outcomes:
measure: Clinical staging
timeFrame: At first diagnosis and over 6 years (Time of retrospective observational analysis of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Recife
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Fernando Maluf, MD
role: PRINCIPAL_INVESTIGATOR
References: