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OpenTrials
Completed

NCT Number: NCT05184504

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CINPAM - Centro Integrado de Pesquisa da Amazônia, Manaus, Amazonas, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

observational study

Other

This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

Primary outcomes

  1. Build a real-life renal cell cancer database in Brazil and Latin America

    Time frame: 2022

Secondary outcomes

  1. 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).

  2. 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.

  3. Characteristics of systemic treatment checklist

    Time frame: 2022

    date of biopsy; dates, type and lines of drug treatment.

  4. Time between diagnosis and start of treatment.

    Time frame: 2022

    Characteristics of systemic treatment checklist

  5. Causes of delay or discontinuation of each treatment checklist

    Time frame: 2022

    Characteristics of systemic treatment

  6. Progression-free survival in each therapeutic line

    Time frame: 2022

  7. Overall survival

    Time frame: 2022

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Ipsen

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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