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

Latin American Cooperative Oncology Group218 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

218

Conditions

Recurrent/Metastatic Urothelial Cancers

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

CLION

Salvador, Estado de Bahia, Brazil

Clínica AMO

Salvador, Estado de Bahia, Brazil

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

LIGA

Curitiba, Paraná, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Socioeconomic chactacteristcs

Health Care Insurance (Public or Private)

Time frame: 2 years

Overall response

Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1

Time frame: 2 years

Duration of response

Defined as the time from response to progression by RECIST v11.1 or death

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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