Clinical-pathological Characterization and Outcomes of Renal Cell Carcinoma in Latin American

February 11, 2025 updated by: Latin American Cooperative Oncology Group

Renal Cell Cancer Registry in Latin American Clinical-phatological Characterization and Outcomes of Renal Cell Carcinoma in Latin America

Observational study, retrospective and prospective, of an analytical nature. Data will be collected from medical records and/or through contact with physicians and institutions (secondary data collection). Patients included retrospectively or prospectively will be followed during the data collection period for the evaluation of treatments and survival. No intervention is planned in this protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 22.250-905
        • CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)
      • São Paulo, Brazil, 01.236-030
        • Hemomed Instituto de Oncologia e Hematologia
      • São Paulo, Brazil, 04.538-135
        • CPO - Centro Paulista de Oncologia (Oncoclínicas)
    • Amazonas
      • Manaus, Amazonas, Brazil, 69.020-030
        • CINPAM - Centro Integrado de Pesquisa da Amazônia
    • Bahia
      • Feira De Santana, Bahia, Brazil, 44.051-754
        • Santa Casa de Misericórdia de Feira de Santana
      • Salvador, Bahia, Brazil, 40.170-110
        • NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60.135-237
        • Oncocentro Ceará (Rede D'or)
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70.390-700
        • Onco-Vida Instituto Especializado de Oncologia
    • Espírito Santo
      • Cachoeiro De Itapemirim, Espírito Santo, Brazil, 29.308-065
        • Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
    • Maranhão
      • São Luís, Maranhão, Brazil, 65.015-460
        • Hospital do Câncer do Maranhão Dr. Tarquínio Lopes Filho
    • Mato Grosso Do Sul
      • Campo Grande, Mato Grosso Do Sul, Brazil, 79.002-061
        • Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo
    • Paraná
      • Curitiba, Paraná, Brazil, 80.510-130
        • ICTR - Instituto do Câncer e Transplante de Curitiba
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58.013-140
        • Hospital Napoleão Laureano
    • Pará
      • Belém, Pará, Brazil, 66.093-032
        • Hospital Porto Dias
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.619-900
        • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
      • Santa Maria, Rio Grande Do Sul, Brazil, 97.015-450
        • Clinica de Hematologia e Oncologia Viver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years or older, who have been diagnosed with renal cell carcinoma (new case or recurrence) since January 2015 and during the study recruitment period.

Description

Inclusion Criteria:

  • Patients ≥ 18 years of age;
  • Proven histology of renal cell carcinoma (any subtype);
  • Pathological diagnosis of renal cell carcinoma in January 2015 or later and new cases diagnosed during the period of recruitment of each center;
  • Have the medical record available and suitable for collecting data on patient characteristics, treatment and outcome.

Exclusion Criteria:

  • Synchronous or other primary tumor within the last 3 years (except thyroid cancer or non melanoma skin).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with pathological diagnosis of renal cell carcinoma
Patients aged 18 years or older, who have been diagnosed with renal cell carcinoma (new case or recurrence) since January 2015 and during the study recruitment period.
Other: Observational study
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Build a real-life renal cell cancer database in Brazil and Latin America
Time Frame: 2022
2022

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic characteristics checklist
Time Frame: 2022
Describe sociodemographic characteristics: age at diagnosis, race, education, family income, occupation, personal habits, family history, comorbidities, treatment funding (public or private), treatment institution (public, private or philanthropic).
2022
Clinicopathological characteristics of patients with renal cell cancer checklist
Time Frame: 2022
date of onset of symptoms, pre-treatment symptoms, histology, clinical and pathological stage, performance status, tests used in staging, date of diagnosis, site of metastases, complications clinics.
2022
Characteristics of systemic treatment checklist
Time Frame: 2022
date of biopsy; dates, type and lines of drug treatment.
2022
Time between diagnosis and start of treatment.
Time Frame: 2022
Characteristics of systemic treatment checklist
2022
Causes of delay or discontinuation of each treatment checklist
Time Frame: 2022
Characteristics of systemic treatment
2022
Progression-free survival in each therapeutic line
Time Frame: 2022
2022
Overall survival
Time Frame: 2022
2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ipsen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: André Poisl Fay, Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LACOG 1120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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