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

Sponsor

Latin American Cooperative Oncology Group (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03942497

Collaborator

Janssen-Cilag Ltd. (Industry)

204

Enrollment

Locations

Anticipated Duration (Months)

22.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Recurrent/Metastatic Urothelial Cancers

Study Design

Study Type:

Observational

Anticipated Enrollment :

204 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 2, 2023

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	CLION	Salvador	BA	Brazil
2	Clínica AMO	Salvador	BA	Brazil
3	Hospital São Rafael	Salvador	BA	Brazil
4	LIGA	Curitiba	PR	Brazil
5	CPO Pucrs	Porto Alegre	RS	Brazil
6	CEPON	Florianópolis	SC	Brazil
7	Beneficência Portuguesa	São Paulo	SP	Brazil
8	Centro Paulista de Oncologia	São Paulo	SP	Brazil
9	Sírio Libanês	São Paulo	SP	Brazil