Trials / Completed
CompletedNCT05257057
Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 91 (actual)
- Sponsor
- WellSpan Health · Academic / Other
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Accepted
Summary
Given that there is a significant prevalence of Lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endometrial intraepithelial neoplasia), it is hypothesized that a diagnosis of endometrial hyperplasia may herald on-going risk of harboring a Lynch Syndrome gene mutation. The purpose of this study is to examine endometrial hyperplasia specimens and compare the frequency of Lynch Syndrome gene mutations between endometrial hyperplasia and endometrial cancer subjects. This will provide a rationale and opportunity for earlier screening, and reduce colon cancer morbidity and mortality secondary to the Lynch syndrome gene.
Detailed description
This is an observational cohort study. Tissue specimens obtained that have been labeled with the diagnosis of endometrial hyperplasia will be identified and their chart reviewed for demographic date of age, race, body mass index, and co-morbidities. The specimen will then be tested via immunohistochemistry for the mismatch repair proteins MLH1, PMS2, MSH2, or MSH 6. Their absence is indicative of Lynch Syndrome. Statistical analysis will then be performed to compare the incidence of Lynch syndrome in endometrial hyperplasia with Lynch Syndrome in endometrial cancer.
Conditions
- Lynch Syndrome
- Endometrial Cancer
- Endometrial Hyperplasia
- Mismatch Repair Deficiency
- Microsatellite Instability
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Immunohistochemical staining | Immunohistochemistry will be performed on the endometrial tissue specimens |
Timeline
- Start date
- 2019-05-08
- Primary completion
- 2023-06-02
- Completion
- 2023-06-02
- First posted
- 2022-02-25
- Last updated
- 2025-03-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05257057. Inclusion in this directory is not an endorsement.