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

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: Completed
• Conditions: Kidney Neoplasms
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

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
      • Clinica 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
Build a real-life renal cell cancer database in Brazil and Latin America	2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	2022
Characteristics of systemic treatment checklist	date of biopsy; dates, type and lines of drug treatment.	2022
Time between diagnosis and start of treatment.	Characteristics of systemic treatment checklist	2022
Causes of delay or discontinuation of each treatment checklist	Characteristics of systemic treatment	2022
Progression-free survival in each therapeutic line		2022
Overall survival		2022

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Ipsen
• Investigators: Principal Investigator: André Poisl Fay, Latin American Cooperative Oncology Group

Publications and helpful links

General Publications

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Strasser-Weippl K, Chavarri-Guerra Y, Villarreal-Garza C, Bychkovsky BL, Debiasi M, Liedke PE, Soto-Perez-de-Celis E, Dizon D, Cazap E, de Lima Lopes G Jr, Touya D, Nunes JS, St Louis J, Vail C, Bukowski A, Ramos-Elias P, Unger-Saldana K, Brandao DF, Ferreyra ME, Luciani S, Nogueira-Rodrigues A, de Carvalho Calabrich AF, Del Carmen MG, Rauh-Hain JA, Schmeler K, Sala R, Goss PE. Progress and remaining challenges for cancer control in Latin America and the Caribbean. Lancet Oncol. 2015 Oct;16(14):1405-38. doi: 10.1016/S1470-2045(15)00218-1.
• Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, Villarreal-Garza C, Unger-Saldana K, Ferreyra M, Debiasi M, Liedke PE, Touya D, Werutsky G, Higgins M, Fan L, Vasconcelos C, Cazap E, Vallejos C, Mohar A, Knaul F, Arreola H, Batura R, Luciani S, Sullivan R, Finkelstein D, Simon S, Barrios C, Kightlinger R, Gelrud A, Bychkovsky V, Lopes G, Stefani S, Blaya M, Souza FH, Santos FS, Kaemmerer A, de Azambuja E, Zorilla AF, Murillo R, Jeronimo J, Tsu V, Carvalho A, Gil CF, Sternberg C, Duenas-Gonzalez A, Sgroi D, Cuello M, Fresco R, Reis RM, Masera G, Gabus R, Ribeiro R, Knust R, Ismael G, Rosenblatt E, Roth B, Villa L, Solares AL, Leon MX, Torres-Vigil I, Covarrubias-Gomez A, Hernandez A, Bertolino M, Schwartsmann G, Santillana S, Esteva F, Fein L, Mano M, Gomez H, Hurlbert M, Durstine A, Azenha G. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013 Apr;14(5):391-436. doi: 10.1016/S1470-2045(13)70048-2.
• Khozin S, Blumenthal GM, Pazdur R. Real-world Data for Clinical Evidence Generation in Oncology. J Natl Cancer Inst. 2017 Nov 1;109(11). doi: 10.1093/jnci/djx187.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): July 11, 2024
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
• Other Study ID 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