Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort

February 10, 2025 updated by: Latin American Cooperative Oncology Group
This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Adrenocortical carcinoma is one of the rarest neoplasms in the world. In Brazil, especially in the South and Southeast regions, the incidence of adrenocortical tumors is around 15 times higher than in the rest of the world, largely attributed to the significant prevalence of the TP53-R337H germline mutation in this population. In view of this characteristic, the clinical and epidemiological characterization of this cohort, as well as the identification of prognostic factors, is of great importance. The starting point for this project was the cohort of 66 participants with adrenal carcinoma included in the final project of the medical residency in clinical oncology at the A.C. Camargo Cancer Center by student Rafael Haikal dos Santos Abduch. The aim is to include case studies from the main Brazilian site that have followed up and treated patients with adrenal carcinoma.

Study Type

Observational

Enrollment (Estimated)

150

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 Backup

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20.230-130
        • Recruiting
        • INCA - Instituto Nacional de Cancer
        • Principal Investigator:
          • Daniel Alves Bulzico
      • São Paulo, Brazil, 01.323-030
        • Recruiting
        • BP - A Beneficencia Portuguesa de São Paulo
        • Principal Investigator:
          • Fábio Roberto Kater
      • São Paulo, Brazil, 01.509-001
        • Recruiting
        • A.C. Camargo Câncer Center
        • Principal Investigator:
          • Milena Shizue Tariki
      • São Paulo, Brazil, 01.327-001
        • Recruiting
        • HAOC - Hospital Alemão Oswaldo Cruz
        • Principal Investigator:
          • Ariel Galapo Kann
    • Ceará
      • Fortaleza, Ceará, Brazil, 60.810-180
        • Recruiting
        • Pronutrir - Suporte Nutricional e Quimioterapia
        • Principal Investigator:
          • Leonardo Atem Gonçalves De Araújo Costa
    • Maranhão
      • São Luis, Maranhão, Brazil, 65.015-460
        • Recruiting
        • Hospital do Câncer do Maranhão Dr. Tarquínio Lopes Filho
        • Principal Investigator:
          • Ana Caroline Fonseca Alves
    • Paraná
      • Curitiba, Paraná, Brazil, 81.520-060
        • Recruiting
        • Hospital Erasto Gaertner
        • Principal Investigator:
          • Murilo de Almeida Luz
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52.011-000
        • Recruiting
        • Hospital Santa Joana Recife (Instituto Américas PE)
        • Principal Investigator:
          • Andréa Lopes Ponte de Souza
    • Santa Catarina
      • Cascavel, Santa Catarina, Brazil, 85.806-300
        • Recruiting
        • UOPECCAN - Hospital do Câncer de Cascavel
        • Principal Investigator:
          • Aline Bobato Lara Gongora
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15.090-000
        • Recruiting
        • FUNFARME - Hospital de Base de São José do Rio Preto
        • Principal Investigator:
          • Luiza Aleixo Barros Leite Ferreira

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Data will be included from 150 participants diagnosed with adrenocortical carcinoma who meet the study's inclusion and exclusion criteria. Data will be collected from the medical records of the included research sites throughout Brazil.

Description

Inclusion Criteria:

  • Participants over 18 years old;
  • Diagnosis of adrenocortical carcinoma with at least one clinical evaluation at the reference institution;
  • Initial diagnosis or recurrence from the year 2000 onwards.

Exclusion Criteria:

  • Participants with insufficient clinical or pathological data in the medical records.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Characterization of Adrenocortical Carcinoma in Brazil
Time Frame: Throughout the study period, an average of 18 months.
This measure aims to capture essential demographic attributes of individuals in Brazil diagnosed with adrenocortical carcinoma. It will include details such as age distribution in years, gender representation, geographic distribution, height in meters, weight in kilograms, as well as racial and ethnic demographics . These insights will contribute to a comprehensive understanding of the demographic landscape of adrenocortical carcinoma within the Brazilian population.
Throughout the study period, an average of 18 months.
Clinical Characterization of Adrenocortical Carcinoma in Brazil
Time Frame: Throughout the study period, an average of 18 months.
This measure aims to capture essential clinical attributes of individuals in Brazil diagnosed with adrenocortical carcinoma. It will include relevant clinical factors such as tumor stage, hormone secretion status, and treatment modalities. These insights will contribute to a comprehensive understanding of the clinical landscape of adrenocortical carcinoma within the Brazilian population.
Throughout the study period, an average of 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Association Between Clinical, Pathological, Epidemiological Factors, and Therapeutic Modalities with Prognosis and Outcomes such as Overall Survival or Recurrence-Free Survival
Time Frame: Throughout the study period, an average of 18 months.
This measure aims to evaluate the correlation between various clinical, pathological, epidemiological factors, and treatment modalities with prognostic indicators and outcomes, including overall survival and recurrence-free survival. It will examine factors such as tumor stage, histological characteristics, patient demographics, treatment regimens, and their impact on long-term prognosis. Insights from this assessment will provide valuable information for optimizing treatment strategies and improving patient outcomes.
Throughout the study period, an average of 18 months.
Evaluating the Impact of Adjuvant Mitotane Use on Progression-Free Survival and Overall Survival
Time Frame: Throughout the study period, an average of 18 months.
This measure seeks to assess the influence of adjuvant mitotane therapy on two crucial clinical endpoints: progression-free survival (PFS) and overall survival (OS). It will investigate the effect of mitotane, when used as an adjuvant treatment, on prolonging the time until disease progression and enhancing overall survival rates in patients with adrenocortical carcinoma. The study will analyze patient data to determine the extent of mitotane's impact on these outcomes, providing valuable insights into its therapeutic efficacy.
Throughout the study period, an average of 18 months.

Collaborators and Investigators

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

Sponsor

Latin American Cooperative Oncology Group

Investigators

  • Principal Investigator: Milena Shizue Tariki, Latin American Cooperative Oncology Group

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)

October 9, 2024

Primary Completion (Estimated)

August 25, 2025

Study Completion (Estimated)

August 25, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0723

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.

Clinical Trials on Carcinoma Adrenal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe