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

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ClinicalTrials.gov Identifier: NCT06014580
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : February 20, 2024
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Endometrial Cancer Other: Observational study

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 Design
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Study Type : Observational
Estimated Enrollment : 282 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014580


Contacts
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Contact: Diana Rostirolla +55 51 3384 5334 diana.rostirolla@lacogcancerresearch.org
Contact: Laura Voelcker +55 51 3384 5334 laura.voelcker@lacogcancerresearch.org

Locations
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Brazil
Santa Casa de Misericórdia de Feira de Santana Recruiting
Feira De Santana, Bahia, Brazil
Principal Investigator: Hyrlana Leal Barbosa Passos         
ICC - Instituto do Câncer do Ceará Recruiting
Fortaleza, Ceará, Brazil, 60.430-230
Principal Investigator: Rosane Oliveira de Sant'Ana         
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO) Recruiting
Cachoeiro De Itapemirim, Espírito Santo, Brazil, 29.308-065
Principal Investigator: Sabina Bandeira Aleixo         
Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo Recruiting
Campo Grande, Mato Grosso Do Sul, Brazil, 79.002-061
Principal Investigator: Cristina dos Anjos Sampaio         
Instituto do Câncer Brasil - Unidade Três Lagoas Recruiting
Três Lagoas, Mato Grosso Do Sul, Brazil, 79.601-001
Principal Investigator: Antônio Carlos Cavalcante Godoy         
UOPECCAN - Hospital do Câncer de Cascavel Recruiting
Cascavel, Santa Catarina, Brazil, 85.806-300
Principal Investigator: Aline Bobato Lara Gongora         
INCA - Instituto Nacional de Câncer Recruiting
Rio De Janeiro, Brazil, 20.230-130
Principal Investigator: Alexssandra Lima dos Santos         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
GlaxoSmithKline
Investigators
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Principal Investigator: Andreia Cristina de Melo Latin American Cooperative Oncology Group
More Information
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Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT06014580    
Other Study ID Numbers: LACOG 0521
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases