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NCT Number: NCT06014580

Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ICC - Instituto do Câncer do Ceará, Fortaleza, Ceará, Brazil

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About this study

This is a retrospective observational cohort study. In this study, we will include patients diagnosed with endometrium cancer from January 2016 to December 2019 in participating sites and collect data on demographics, clinicopathological characteristics, treatment patterns, and outcomes. Data will be collected from medical records in selected centers that comprise different regions of Brazil.

The patient data sources will be the medical records of the patients. Patients will continue to receive treatment and clinical evaluations for endometrial cancer according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. To minimize patient selection bias, physicians should invite all consecutive eligible patients.

This study also provides for the collection and archiving of tumor tissue material. The samples will be tested to characterize the molecular subtype of endometrial cancer and will be sequentially stored in a biorepository to enable future translational studies, according to national regulations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer

    Time frame: At the time of diagnosis.

    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.

  2. Molecular Profile Analysis of Endometrial Cancer Cases

    Time frame: Throughout the study period, an average of 36 month.

    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.

  3. Treatment Patterns for Endometrial Cancer in Brazil

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

    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.

  4. Endometrial Cancer Outcomes in the Brazilian Population

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

    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.

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • GlaxoSmithKline

Registry information

Acronym: MADONNA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2023
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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