Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

NCT ID: NCT03942497

Last Updated: 2022-09-27

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

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-02-28

Brief Summary

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The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.

Detailed Description

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Conditions

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Recurrent/Metastatic Urothelial Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age at least 18 years;
2. Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
3. Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
4. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
5. Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.

Exclusion Criteria

1. Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers);
2. Pure non-urothelial carcinoma histology.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustavo Werutsky, MD

Role: STUDY_DIRECTOR

Latin American Cooperative Oncology Group

Locations

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CLION

Salvador, Estado de Bahia, Brazil

Site Status

Clínica AMO

Salvador, Estado de Bahia, Brazil

Site Status

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Site Status

LIGA

Curitiba, Paraná, Brazil

Site Status

CPO Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

CEPON

Florianópolis, Santa Catarina, Brazil

Site Status

Beneficência Portuguesa

São Paulo, São Paulo, Brazil

Site Status

Centro Paulista de Oncologia

São Paulo, São Paulo, Brazil

Site Status

Sírio Libanês

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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1. Milowsky MI, Rumble RB, Booth CM, et al. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016;34(16):1945-1952. doi:10.1200/JCO.2015.65.9797 2. Instituto Nacional de Câncer José Alencar Gomes. Estimativa 2018: Incidência de Câncer No Brasil. Rio de Janeiro: INCA; 2018. http://www.inca.gov.br/estimativa/2018. 3. International Agency for Research on Cancer, International Association of Cancer Registries. Cancer Incidence in Five Continents. Volume X Volume X.; 2014. http://www.iarc.fr/en/publications/pdfs-online/epi/sp164/. Accessed November 21, 2018. 4. Secretaria de Estado da Saúde de São Paulo. FOSP - Fundação Oncocentro de São Paulo. http://www.fosp.saude.sp.gov.br/. Accessed October 30, 2018. 5. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-1259. doi:10.1016/S0140-6736(00)02799-9

Reference Type BACKGROUND

Other Identifiers

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LACOG 1518

Identifier Type: -

Identifier Source: org_study_id

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