Brazilian Reality of Urinary Bladder Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-04-18

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Urothelial Carcinoma Non Muscle Invasive Bladder Cancer Muscle-invasive Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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);

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No