Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome
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|ClinicalTrials.gov Identifier: NCT05257057|
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : June 6, 2022
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.
|Condition or disease||Intervention/treatment|
|Lynch Syndrome Endometrial Cancer Endometrial Hyperplasia Mismatch Repair Deficiency Microsatellite Instability||Diagnostic Test: Immunohistochemical staining|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome|
|Actual Study Start Date :||May 8, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||January 2023|
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
Immunohistochemistry will be performed on the endometrial tissue specimens
- Lynch Syndrome Screen Positive Rate [ Time Frame: 2014-2022 ]This is the rate of subjects who screen positive for Lynch Syndrome based on immunohistochemical staining
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05257057
|Contact: Eav Lim, DO||(717) email@example.com|
|Contact: Kathryn Kennedy, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|York, Pennsylvania, United States, 17403|
|Contact: Eav Lim, DO 717-741-8100 email@example.com|
|Principal Investigator:||Eav Lim, DO||WellSpan Health-York Cancer Center|