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

Latin American Cooperative Oncology Group (LACOG)

Status

Active, not recruiting

Conditions

Endometrial Cancer

Treatments

Other: Observational study

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06014580

LACOG 0521

Details and patient eligibility

About

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.

Full 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.

Enrollment

276 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.