Clinical trial NCT06279442: Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort
Official title: Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma Adrenal
Carcinoma, Adrenocortical Recurrent
Keywords: Carcinoma adrenocortical
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Demographic Characterization of Adrenocortical Carcinoma in Brazil
timeFrame: Throughout the study period, an average of 18 months.
measure: Clinical Characterization of Adrenocortical Carcinoma in Brazil
timeFrame: Throughout the study period, an average of 18 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Pronutrir - Suporte Nutricional e Quimioterapia
state: Ceará
city: São Luis
country: Brazil
facility: Hospital do Câncer do Maranhão Dr. Tarquínio Lopes Filho
state: Maranhão
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Recife
country: Brazil
facility: Hospital Santa Joana Recife (Instituto Américas PE)
state: Pernambuco
city: Cascavel
country: Brazil
facility: UOPECCAN - Hospital do Câncer de Cascavel
state: Santa Catarina
city: São José do Rio Preto
country: Brazil
facility: FUNFARME - Hospital de Base de São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
city: São Paulo
country: Brazil
facility: BP - A Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: HAOC - Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Milena Shizue Tariki
role: PRINCIPAL_INVESTIGATOR
References: