Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil (MADONNA)

March 6, 2025 updated by: Latin American Cooperative Oncology Group
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20.230-130
        • INCA - Instituto Nacional de Cancer
    • Bahia
      • Feira De Santana, Bahia, Brazil
        • Santa Casa de Misericórdia de Feira de Santana
    • Ceará
      • Fortaleza, Ceará, Brazil, 60.430-230
        • ICC - Instituto do Câncer do Ceará
    • Espírito Santo
      • Cachoeiro De Itapemirim, Espírito Santo, Brazil, 29.308-065
        • Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
    • Mato Grosso Do Sul
      • Campo Grande, Mato Grosso Do Sul, Brazil, 79.002-061
        • Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo
      • Três Lagoas, Mato Grosso Do Sul, Brazil, 79.601-001
        • Instituto do Câncer Brasil - Unidade Três Lagoas
    • Santa Catarina
      • Cascavel, Santa Catarina, Brazil, 85.806-300
        • UOPECCAN - Hospital do Câncer de Cascavel

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

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

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of diagnosis.
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.
Throughout the study period, an average of 36 month.
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.
From diagnosis to completion of treatment, between January 2016 and December 2019.
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.
From diagnosis to the end of the study follow-up period, an average of 36 months.

Collaborators and Investigators

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

Sponsor

Latin American Cooperative Oncology Group

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Andreia Cristina de Melo, 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)

November 27, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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