Kidney NeoplasmsNCT05184504
Clinical-pathological Characterization and Outcomes of Renal Cell Carcinoma in Latin American
An observational study of Kidney Neoplasms, run by Latin American Cooperative Oncology Group at 16 sites in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Observational study
- How many people
- 211 participants
- Where
- 16 sitesBrazil
- Study dates
- 1 Sep 2022to 11 Jul 2024
- 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 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.
Who may be able to join
- 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.
Who cannot join
- Synchronous or other primary tumor within the last 3 years (except thyroid cancer or non melanoma skin).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Brazil16 sites
Hospital Porto Dias
Belém, Pará, 66.093-032
Onco-Vida Instituto Especializado de Oncologia
Brasília, Federal District, 70.390-700
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Cachoeiro de Itapemirim, Espírito Santo, 29.308-065
Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo
Campo Grande, Mato Grosso do Sul, 79.002-061
ICTR - Instituto do Câncer e Transplante de Curitiba
Curitiba, Paraná, 80.510-130
Santa Casa de Misericórdia de Feira de Santana
Feira de Santana, Estado de Bahia, 44.051-754
Oncocentro Ceará (Rede D'or)
Fortaleza, Ceará, 60.135-237
Hospital Napoleão Laureano
João Pessoa, Paraíba, 58.013-140
CINPAM - Centro Integrado de Pesquisa da Amazônia
Manaus, Amazonas, 69.020-030
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90.619-900
CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)
Rio de Janeiro, 22.250-905
NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)
Salvador, Estado de Bahia, 40.170-110
Clínica de Hematologia e Oncologia Viver
Santa Maria, Rio Grande do Sul, 97.015-450
Hospital do Câncer do Maranhão Dr. Tarquínio Lopes Filho
São Luís, Maranhão, 65.015-460
Hemomed Instituto de Oncologia e Hematologia
São Paulo, 01.236-030
CPO - Centro Paulista de Oncologia (Oncoclínicas)
São Paulo, 04.538-135
About this study
Official title: 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.
- Conditions
- Kidney Neoplasms
- Being tested
- Observational study
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Build a real-life renal cell cancer database in Brazil and Latin America
Measured: 2022
Secondary outcomes (7)
Sociodemographic characteristics checklist
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).
Measured: 2022
Clinicopathological characteristics of patients with renal cell cancer checklist
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.
Measured: 2022
Characteristics of systemic treatment checklist
date of biopsy; dates, type and lines of drug treatment.
Measured: 2022
Time between diagnosis and start of treatment.
Characteristics of systemic treatment checklist
Measured: 2022
Causes of delay or discontinuation of each treatment checklist
Characteristics of systemic treatment
Measured: 2022
Progression-free survival in each therapeutic line
Measured: 2022
Overall survival
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Sep 2022
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies 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
- Other
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- André Poisl Fay, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184504
- Sponsor's protocol ID
- LACOG 1120
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Cell Cancer Registry in Latin American Clinical-phatological Characterization and Outcomes of Renal Cell Carcinoma in Latin America
- ClinicalTrials.gov ID
- NCT05184504
- Acronym / sponsor ID
- LACOG 1120
- Conditions
- Kidney Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 11 Jan 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pathological diagnosis of renal cell carcinoma | – | Other: Observational studyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Synchronous or other primary tumor within the last 3 years (except thyroid cancer or non melanoma skin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. | Other | Patients with pathological diagnosis of renal cell carcinoma |
Primary outcome
Build a real-life renal cell cancer database in Brazil and Latin America
Time frame: 2022
7 secondary outcomes
Sociodemographic characteristics checklist
Time frame: 2022
Clinicopathological characteristics of patients with renal cell cancer checklist
Time frame: 2022
Characteristics of systemic treatment checklist
Time frame: 2022
Time between diagnosis and start of treatment.
Time frame: 2022
Causes of delay or discontinuation of each treatment checklist
Time frame: 2022
Progression-free survival in each therapeutic line
Time frame: 2022
Overall survival
Time frame: 2022
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 2025.
- Individual participant dataSharing planned: No
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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.
André Poisl Fay principal investigator
Latin American Cooperative Oncology Group
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasms, run by Latin American Cooperative Oncology Group at 16 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 4 inclusion and 1 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 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Build a real-life renal cell cancer database in Brazil and Latin America (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2025.