Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

NCT06014580 | Active Not Recruiting

• 1 other identifier: LACOG 0521
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 7

Brief Summary

An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is necessary to understand the high frequency of advanced disease. A better understanding of the current situation will generate essential data for the future development of national or international cooperative programs that aim to improve outcomes in these patients and generate additional knowledge for much-needed clinical trials in this population.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (4)

• Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer

  This measure encompasses key epidemiological factors of the Brazilian population diagnosed with endometrial cancer, including age distribution, racial and ethnic demographics, geographic regions, and relevant comorbidities. These details will provide insights into the demographic makeup of the study population.

  At the time of diagnosis.

• Molecular Profile Analysis of Endometrial Cancer Cases

  This measure focuses on analyzing the molecular profile of endometrial cancer cases in the Brazilian population. It includes information about specific genetic mutations, biomarkers, and molecular subtypes that are relevant to endometrial cancer. Understanding the molecular landscape can contribute to insights into disease progression and potential targeted therapies.

  Throughout the study period, an average of 36 month.

• Treatment Patterns for Endometrial Cancer in Brazil

  This measure examines the treatment patterns employed for endometrial cancer within the Brazilian population. It includes details about types of treatments received, such as surgery, chemotherapy, radiation therapy, and hormonal therapy. Additionally, it explores the utilization of targeted therapies or immunotherapies.

  From diagnosis to completion of treatment, between January 2016 and December 2019.

• Endometrial Cancer Outcomes in the Brazilian Population

  This measure assesses the outcomes of endometrial cancer cases in the Brazilian population. It includes survival rates, disease recurrence rates, response to treatment, and overall disease progression. By evaluating these outcomes, a comprehensive understanding of the disease's impact on the population can be achieved.

  From diagnosis to the end of the study follow-up period, an average of 36 months.

Study Arms (1)

Patients diagnosed with endometrial cancer

Patients diagnosed with endometrial cancer between January 2016 and December 2019 at participating sites will be included.

Other: Observational study

Interventions

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.

Patients diagnosed with endometrial cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women diagnosed with endometrial cancer between January 2016 and December 2019 at participating research sites.

You may qualify if:

• Women ≥18 years
• Histological diagnosis of endometrial carcinoma.
• Diagnosis of endometrial cancer between January 2016 and December 2019.
• FIGO (International Federation of Gynecology and Obstetrics, 2018) Stage I - IV.
• Site and investigator with access to a medical record chart from which data can be abstracted.
• Presence of a sample of tumor tissue (primary tumor or metastasis) available for biomarker testing.

You may not qualify if:

• Noninvasive endometrial cancer.
• Patients with a history of concurrent or previously treated non-endometrial malignancies except for appropriately treated 1) non -metastatic non-melanoma skin cancer and/or 2) non-metastatic low-grade thyroid tumors and/or 3) in situ carcinomas, including cervix, colon, and skin.
• Nonepithelial histology (leiomyosarcoma, adenosarcoma, endometrial stromal sarcoma, undifferentiated sarcoma, or other mesenchymal tumors.

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• GlaxoSmithKline: collaborator

Study Sites (7)

ICC - Instituto do Câncer do Ceará

Fortaleza, Ceará, 60.430-230, Brazil

Location

Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)

Cachoeiro de Itapemirim, Espírito Santo, 29.308-065, Brazil

Location

Santa Casa de Misericórdia de Feira de Santana

Feira de Santana, Estado de Bahia, Brazil

Location

Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo

Campo Grande, Mato Grosso do Sul, 79.002-061, Brazil

Location

Instituto do Câncer Brasil - Unidade Três Lagoas

Três Lagoas, Mato Grosso do Sul, 79.601-001, Brazil

Location

UOPECCAN - Hospital do Câncer de Cascavel

Cascavel, Santa Catarina, 85.806-300, Brazil

Location

INCA - Instituto Nacional de Câncer

Rio de Janeiro, 20.230-130, Brazil

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Andreia Cristina de Melo

  Latin American Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 28, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

BR (7)