Clinical trial NCT06014580: Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil
Official title: Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-08-28
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed with endometrial cancer between January 2016 and December 2019 at participating research sites.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer
timeFrame: At the time of diagnosis.
measure: Molecular Profile Analysis of Endometrial Cancer Cases
timeFrame: Throughout the study period, an average of 36 month.
measure: Treatment Patterns for Endometrial Cancer in Brazil
timeFrame: From diagnosis to completion of treatment, between January 2016 and December 2019.
measure: Endometrial Cancer Outcomes in the Brazilian Population
timeFrame: From diagnosis to the end of the study follow-up period, an average of 36 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Feira De Santana
country: Brazil
facility: Santa Casa de Misericórdia de Feira de Santana
state: Bahia
city: Fortaleza
country: Brazil
facility: ICC - Instituto do Câncer do Ceará
state: Ceará
city: Cachoeiro De Itapemirim
country: Brazil
facility: Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
state: Espírito Santo
city: Campo Grande
country: Brazil
facility: Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo
state: Mato Grosso Do Sul
city: Três Lagoas
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Três Lagoas
state: Mato Grosso Do Sul
city: Cascavel
country: Brazil
facility: UOPECCAN - Hospital do Câncer de Cascavel
state: Santa Catarina
city: Rio De Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Andreia Cristina de Melo
role: PRINCIPAL_INVESTIGATOR
References: