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

September 1, 2026 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

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.

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

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.
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

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
    • Ceará
      • Fortaleza, Ceará, Brazil, 60.810-180
        • Pronutrir - Suporte Nutricional e Quimioterapia
    • Maranhão
      • São Luís, Maranhão, Brazil, 65.015-460
        • Hospital do Câncer do Maranhão Dr. Tarquínio Lopes Filho
    • Paraná
      • Curitiba, Paraná, Brazil, 81.520-060
        • Hospital Erasto Gaertner
    • Pará
      • Belém, Pará, Brazil, 66073-000
        • HUJBB - Hospital Universitário João de Barros Barreto da UFPA
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52.011-000
        • Hospital Santa Joana Recife (Instituto Américas PE)
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20.230-130
        • INCA - Instituto Nacional de Câncer
    • Santa Catarina
      • Cascavel, Santa Catarina, Brazil, 85.806-300
        • UOPECCAN - Hospital do Câncer de Cascavel
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Amor de Barretos
      • São José do Rio Preto, São Paulo, Brazil, 15.090-000
        • FUNFARME - Hospital de Base de São José do Rio Preto
      • São Paulo, São Paulo, Brazil, 01.509-001
        • A.C. Camargo Cancer Center
      • São Paulo, São Paulo, Brazil, 01.323-030
        • BP - A Beneficência Portuguesa de São Paulo
      • São Paulo, São Paulo, Brazil, 01.327-001
        • HAOC - Hospital Alemão Oswaldo Cruz

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

  • 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

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
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

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
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

Sponsor

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

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: 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)

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.
October 9, 2024

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.
September 23, 2025

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.
September 23, 2025

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).
February 19, 2024

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.
February 19, 2024

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.
February 28, 2024

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.
September 2, 2026

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.
September 1, 2026

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.
August 1, 2026

More Information

Terms related to this study

Keywords

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 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings