Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-27

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Endometrial Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients diagnosed with endometrial cancer

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

Observational study

Intervention Type OTHER

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

Interventions

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Observational study

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No