Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

Urothelial Carcinoma Clinical Trial

Official title:

Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER: Multicenter Retrospective Study (Real World Evidence - RWE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945108
• Other study ID #: D133HR00023
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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);

Related Conditions & MeSH terms

• Muscle-invasive Bladder Cancer
• Non Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Locations

Country	Name	City	State
Brazil	Associacao Mario Penna (Nucleo de Ensino E Pesquisas Mario Penn	Belo Horizonte	Minas Gerais
Brazil	Centro de Pesquisas Oncológicas - CEPON	Florianópolis	Santa Catarina
Brazil	Hospital Moinhos de Vento - HMV	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto de Medicina Integral Professor Fernando Figueira - IMIP	Recife	Pernambuco
Brazil	Ensino E Terapia de Inovação Clínica Amo	Rio Vermelho	Salvador
Brazil	Fundacao Faculdade Regional de Medicina S J Rio Preto - Cip	São José do Rio Preto	São Paulo
Brazil	Hospital Israelita Albert Einstein	São Paulo
Brazil	Hospital Municipal da Vila Santa Catarina	São Paulo
Brazil	Instituto de Assistência Médica do Servidor Público do Estado de São Pualo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)