Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome

Completed

Conditions studied: Lynch Syndrome, Endometrial Cancer, Endometrial Hyperplasia, Mismatch Repair Deficiency, Microsatellite Instability

In brief

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.

Key facts

Study ID

NCT05257057

Run by

WellSpan Health

People needed

91

Starts

2019-05-08

Expected to finish

2023-06-02

Last updated by the study team

2025-03-28

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Appropriate specimen, hysterectomy or biopsy with final labeled diagnosis of endometrial hyperplasia of any grade

You may not qualify if…

• Any specimen that is later associated with endometrial cancer in subsequent pathology exam

Where it is running

• WellSpan — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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