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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Socioeconomic chactacteristcs | Health Care Insurance (Public or Private) | 2 years |
| Overall response | Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Werutsky, MD | Latin American Cooperative Oncology Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLION | Salvador | Estado de Bahia | Brazil | |||
| Clínica AMO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
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Archived tumor samples from Formalin-Fixed Paraffin-Embedded (FFPE) blocks or slides.
| 2 years |
| Duration of response | Defined as the time from response to progression by RECIST v11.1 or death | 2 years |
| 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 |
| Salvador |
| Estado de Bahia |
| Brazil |
| Hospital São Rafael | Salvador | Estado de Bahia | Brazil |
| LIGA | Curitiba | Paraná | Brazil |
| CPO Pucrs | Porto Alegre | Rio Grande do Sul | Brazil |
| CEPON | Florianópolis | Santa Catarina | Brazil |
| Beneficência Portuguesa | São Paulo | São Paulo | Brazil |
| Centro Paulista de Oncologia | São Paulo | São Paulo | Brazil |
| Sírio Libanês | São Paulo | São Paulo | Brazil |
| D009369 | Neoplasms |