NCT03942497CompletedNot Applicable
Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
Latin American Cooperative Oncology Group9 sites in 1 country218 target enrollmentStarted: August 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 218
- Locations
- 9
- Primary Endpoint
- Epidemiology
Study Overview
Brief Summary
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age at least 18 years;
- •Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
- •Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
- •Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
- •Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.
Exclusion Criteria
- •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);
- •Pure non-urothelial carcinoma histology.
Outcomes
Primary Outcomes
Epidemiology
Time Frame: 2 years
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.
Secondary Outcomes
- Socioeconomic chactacteristcs(2 years)
- Overall response(2 years)
- PFS(2 years)
- Duration of response(2 years)
Investigators
Study Sites (9)
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