Endometrial Neoplasms Endometrial Cancer
Conditions
Interventions
This is a single-arm observational and prospective study with two hundred participants where there is no randomization or allocation process for participants and there is no masking or blinding since
Sponsors
Instituto de Medicina Integral Professor Fernando Figueira
Instituto de Medicina Integral Professor Fernando Figueira
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; aged eighteen years or older; confirmed histopathological diagnosis of carcinoma of the uterine body; clinical stage I to IV; medical records available and suitable for data collection at the institution; voluntary agreement to participate in the study by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Patients diagnosed with non-invasive uterine carcinoma; cervical carcinoma; uterine sarcomas; pregnant women; women with a history of synchronous tumors; a second primary tumor diagnosed within the last five years, excluding prior cases of thyroid cancer or non-melanoma skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to map the prevalence of molecular alterations and describe the proportion of cases with microsatellite instability in a population of two hundred women with endometrial carcinoma. This outcome will be measured through laboratory immunohistochemistry assays for the detection of mismatch repair proteins, estrogen and progesterone receptors, tumor protein fifty-three, and human epidermal growth factor receptor two, associated with Next-Generation Sequencing for genetic evaluation of the genes mutL homolog one, mutS homolog two, mutS homolog six, postmeiotic segregation increased two, human epidermal growth factor receptor two, tumor protein fifty-three, and polymerase epsilon. Laboratory data will be measured and evaluated from tissue samples collected at the baseline of the study and processed within the maximum two-year follow-up period of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe overall survival and disease progression-free or recurrence-free survival rates, in addition to identifying the main time bottlenecks in each participant's diagnostic and treatment journey. These outcomes will be statistically measured by survival estimation curves constructed using the Kaplan-Meier method and compared using the logrank test, while clinicopathological and sociodemographic associations will be quantitatively evaluated using Pearson's chi-square tests and Student's t-test. Clinical and temporal data of the participants will be systematically collected and extracted from medical records continuously during scheduled visits at months zero, three, six, twelve, and twenty-four of follow-up. | — |
Countries
BR
Contacts
Public ContactCarla Rameri de Azevedo
Instituto de Medicina Integral Professor Fernando Figueira
Outcome results
None listed