NCT03942497

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 12, 2026

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

April 25, 2019

Last Update Submit

February 11, 2026

Conditions

Recurrent/Metastatic Urothelial Cancers

Keywords

metastaticrecurrenturothelial cancersrenal pelvisureterbladderurethra

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (4)

  • Socioeconomic chactacteristcs

    2 years

  • Overall response

    2 years

  • Duration of response

    2 years

  • PFS

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CLION

Salvador, Estado de Bahia, Brazil

Location

Clínica AMO

Salvador, Estado de Bahia, Brazil

Location

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Location

LIGA

Curitiba, Paraná, Brazil

Location

CPO Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Location

CEPON

Florianópolis, Santa Catarina, Brazil

Location

Beneficência Portuguesa

São Paulo, São Paulo, Brazil

Location

Centro Paulista de Oncologia

São Paulo, São Paulo, Brazil

Location

Sírio Libanês

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 1. Milowsky MI, Rumble RB, Booth CM, et al. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016;34(16):1945-1952. doi:10.1200/JCO.2015.65.9797 2. Instituto Nacional de Câncer José Alencar Gomes. Estimativa 2018: Incidência de Câncer No Brasil. Rio de Janeiro: INCA; 2018. http://www.inca.gov.br/estimativa/2018. 3. International Agency for Research on Cancer, International Association of Cancer Registries. Cancer Incidence in Five Continents. Volume X Volume X.; 2014. http://www.iarc.fr/en/publications/pdfs-online/epi/sp164/. Accessed November 21, 2018. 4. Secretaria de Estado da Saúde de São Paulo. FOSP - Fundação Oncocentro de São Paulo. http://www.fosp.saude.sp.gov.br/. Accessed October 30, 2018. 5. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-1259. doi:10.1016/S0140-6736(00)02799-9

    BACKGROUND

Biospecimen

Archived tumor samples from Formalin-Fixed Paraffin-Embedded (FFPE) blocks or slides.

MeSH Terms

Conditions

RecurrenceNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasms

Study Officials

  • Gustavo Werutsky, MD

    Latin American Cooperative Oncology Group

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 8, 2019

Study Start

August 1, 2019

Primary Completion

August 31, 2021

Study Completion

February 28, 2022

Last Updated

February 12, 2026

Record last verified: 2022-09

Locations

BR(9)