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

Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03942497

Enrollment

218

Registered

2019-05-08

Start date

2019-08-01

Completion date

2022-02-28

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent/Metastatic Urothelial Cancers

Keywords

metastatic, recurrent, urothelial cancers, renal pelvis, ureter, bladder, urethra

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Epidemiology	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

Measure	Time frame	Description
Socioeconomic chactacteristcs	2 years	Health Care Insurance (Public or Private)
Overall response	2 years	Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1
Duration of response	2 years	Defined as the time from response to progression by RECIST v11.1 or death
PFS	2 years	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.

Countries

Brazil

Contacts

STUDY_DIRECTORGustavo Werutsky, MD

Latin American Cooperative Oncology Group

Outcome results