Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

Endometrial Cancer Clinical Trial

— MADONNA  

Official title:

Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014580
• Other study ID #: LACOG 0521
• Status: Recruiting
• Start date: November 27, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Latin American Cooperative Oncology Group
• Contact: Diana Rostirolla
• Phone: +55 51 3384 5334
• Email: diana.rostirolla[@]lacogcancerresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)	Cachoeiro De Itapemirim	Espírito Santo
Brazil	Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo	Campo Grande	Mato Grosso Do Sul
Brazil	UOPECCAN - Hospital do Câncer de Cascavel	Cascavel	Santa Catarina
Brazil	Santa Casa de Misericórdia de Feira de Santana	Feira De Santana	Bahia
Brazil	ICC - Instituto do Câncer do Ceará	Fortaleza	Ceará
Brazil	INCA - Instituto Nacional de Câncer	Rio De Janeiro
Brazil	Instituto do Câncer Brasil - Unidade Três Lagoas	Três Lagoas	Mato Grosso Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.