Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Colorectal Neoplasms, Hereditary Nonpolyposis
Endometrial Cancer
Endometrial Hyperplasia
Endometrial Neoplasms
Hyperplasia
Lynch Syndrome
Microsatellite Instability
Mismatch Repair Deficiency
Syndrome

Clinical Trial Details

NCT number	NCT05257057
Study type	Observational
Source	WellSpan Health
Contact
Status	Active, not recruiting
Phase
Start date	May 8, 2019
Completion date	December 2024

View Details

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