Recurrent/Metastatic Urothelial CancersNCT03942497
Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America
An observational study of Recurrent/Metastatic Urothelial Cancers, run by Latin American Cooperative Oncology Group at 9 sites in Brazil.
Trial summary
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent/Metastatic Urothelial Cancers
- How many people
- 218 participants
- Where
- 9 sitesBrazil
- Study dates
- 1 Aug 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
LIGA
Curitiba, Paraná
CEPON
Florianópolis, Santa Catarina
CPO Pucrs
Porto Alegre, Rio Grande do Sul
CLION
Salvador, Estado de Bahia
Clínica AMO
Salvador, Estado de Bahia
Hospital São Rafael
Salvador, Estado de Bahia
Beneficência Portuguesa
São Paulo, São Paulo
Centro Paulista de Oncologia
São Paulo, São Paulo
Sírio Libanês
São Paulo, São Paulo
About this study
Official title: Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.
- Conditions
- Recurrent/Metastatic Urothelial Cancers
- Keywords
- metastatic, recurrent, urothelial cancers, renal pelvis, ureter, bladder, urethra
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
Socioeconomic chactacteristcs
Health Care Insurance (Public or Private)
Measured: 2 years
Overall response
Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1
Measured: 2 years
Duration of response
Defined as the time from response to progression by RECIST v11.1 or death
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Aug 2019
- Primary completion31 Aug 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent/Metastatic Urothelial CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Gustavo Werutsky, MD, Study director, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942497
- Sponsor's protocol ID
- LACOG 1518
- Status last verified
- Sep 2022
- First submitted
- 25 Apr 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
- ClinicalTrials.gov ID
- NCT03942497
- Acronym / sponsor ID
- LACOG 1518
- Conditions
- Recurrent/Metastatic Urothelial Cancers
- Keywords
- metastatic, recurrent, urothelial cancers, renal pelvis, ureter, bladder, urethra
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Socioeconomic chactacteristcs
Time frame: 2 years
Overall response
Time frame: 2 years
Duration of response
Time frame: 2 years
PFS
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background1. 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Werutsky, MD study director
Latin American Cooperative Oncology Group
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent/Metastatic Urothelial Cancers, run by Latin American Cooperative Oncology Group at 9 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.