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Trial Title:
Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil
NCT ID:
NCT06014580
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Observational study
Description:
This is an observational study; patients will not be exposed to clinical interventions
different from those belonging to the standard of care.
Arm group label:
Patients diagnosed with endometrial cancer
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.
Criteria for eligibility:
Study pop:
Women diagnosed with endometrial cancer between January 2016 and December 2019 at
participating research sites.
Sampling method:
Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Santa Casa de Misericórdia de Feira de Santana
Address:
City:
Feira De Santana
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Hyrlana Leal Barbosa Passos
Email:
Principal Investigator
Facility:
Name:
ICC - Instituto do Câncer do Ceará
Address:
City:
Fortaleza
Zip:
60.430-230
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Rosane Oliveira de Sant'Ana
Email:
Principal Investigator
Facility:
Name:
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Address:
City:
Cachoeiro De Itapemirim
Zip:
29.308-065
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Sabina Bandeira Aleixo
Email:
Principal Investigator
Facility:
Name:
Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo
Address:
City:
Campo Grande
Zip:
79.002-061
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Cristina dos Anjos Sampaio
Email:
Principal Investigator
Facility:
Name:
Instituto do Câncer Brasil - Unidade Três Lagoas
Address:
City:
Três Lagoas
Zip:
79.601-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Antônio Carlos Cavalcante Godoy
Email:
Principal Investigator
Facility:
Name:
UOPECCAN - Hospital do Câncer de Cascavel
Address:
City:
Cascavel
Zip:
85.806-300
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Aline Bobato Lara Gongora
Email:
Principal Investigator
Facility:
Name:
INCA - Instituto Nacional de Câncer
Address:
City:
Rio De Janeiro
Zip:
20.230-130
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Alexssandra Lima dos Santos
Email:
Principal Investigator
Start date:
November 27, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Latin American Cooperative Oncology Group
Agency class:
Other
Collaborator:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
Latin American Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06014580
