Skip to main content
OpenTrials
Completed

NCT Number: NCT03942497

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent/Metastatic Urothelial Cancers Disease Attributes Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CLION, Salvador, Estado de Bahia, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Socioeconomic chactacteristcs

    Time frame: 2 years

    Health Care Insurance (Public or Private)

  2. Overall response

    Time frame: 2 years

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

  3. Duration of response

    Time frame: 2 years

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

  4. PFS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 8, 2019
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.