Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome

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

Intervention / Treatment
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* Diagnostic Test: Immunohistochemical staining


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Appropriate specimen, hysterectomy or biopsy with final labeled diagnosis of endometrial hyperplasia of any grade Exclusion Criteria: Any specimen that is later associated with endometrial cancer in subsequent pathology exam

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrial hyperplasia<br>These are patients with a diagnosis of endometrial hyperplasia at WellSpan in the study time frame diagnosed via endometrial biopsy, dilation and curettage, or hysterectomy. | Diagnostic Test: Immunohistochemical staining<br>* Immunohistochemistry will be performed on the endometrial tissue specimens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lynch Syndrome Screen Positive Rate | This is the rate of subjects who screen positive for Lynch Syndrome based on immunohistochemical staining | 2014-2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lynch Syndrome, endometrial hyperplasia, endometrial cancer, immunohistochemistry, mismatch repair