Recurrent/Metastatic Urothelial Cancers Clinical Trial
Official title:
Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
| NCT number | NCT03942497 |
| Other study ID # | LACOG 1518 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 1, 2019 |
| Est. completion date | February 28, 2022 |
| Verified date | September 2022 |
| Source | Latin American Cooperative Oncology Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.
| Status | Completed |
| Enrollment | 218 |
| Est. completion date | February 28, 2022 |
| Est. primary completion date | August 31, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | LIGA | Curitiba | PR |
| Brazil | CEPON | Florianópolis | SC |
| Brazil | CPO Pucrs | Porto Alegre | RS |
| Brazil | Clínica AMO | Salvador | BA |
| Brazil | CLION | Salvador | BA |
| Brazil | Hospital São Rafael | Salvador | BA |
| Brazil | Beneficência Portuguesa | São Paulo | SP |
| Brazil | Centro Paulista de Oncologia | São Paulo | SP |
| Brazil | Sírio Libanês | São Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Latin American Cooperative Oncology Group | Janssen-Cilag Ltd. |
Brazil,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Epidemiology | Overall survival (OS) will be defined from the date of treatment initiation to date of death from any cause. In case of patients that received palliative care only, OS will be defined from date of diagnosis of advanced disease to date of death from any cause. Patients who are alive will be censored at the date of last known contact. | 2 years | |
| Secondary | Socioeconomic chactacteristcs | Health Care Insurance (Public or Private) | 2 years | |
| Secondary | Overall response | Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1 | 2 years | |
| Secondary | Duration of response | Defined as the time from response to progression by RECIST v11.1 or death | 2 years | |
| Secondary | PFS | Progression-free survival (PFS) will be defined from date of treatment initiation to date of disease progression or death from any cause, whichever occurs first in each line. | 2 years |