Clinical trial NCT03942497: Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America
Official title: Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent/Metastatic Urothelial Cancers
Keywords: metastatic
recurrent
urothelial cancers
renal pelvis
ureter
bladder
urethra
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2019-05-08
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Epidemiology
timeFrame: 2 years
Secondary outcomes:
measure: Socioeconomic chactacteristcs
timeFrame: 2 years
measure: Overall response
timeFrame: 2 years
measure: Duration of response
timeFrame: 2 years
measure: PFS
timeFrame: 2 years
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: CLION
state: BA
city: Salvador
country: Brazil
facility: Clínica AMO
state: BA
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: BA
city: Curitiba
country: Brazil
facility: LIGA
state: PR
city: Porto Alegre
country: Brazil
facility: CPO Pucrs
state: RS
city: Florianópolis
country: Brazil
facility: CEPON
state: SC
city: São Paulo
country: Brazil
facility: Beneficência Portuguesa
state: SP
city: São Paulo
country: Brazil
facility: Centro Paulista de Oncologia
state: SP
city: São Paulo
country: Brazil
facility: Sírio Libanês
state: SP
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
References:
citation: 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