An observational study in Lynch Syndrome, Endometrial Cancer and Endometrial Hyperplasia, sponsored by WellSpan Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by WellSpan Health · Observational
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.
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.
145 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 59 are open to participants now.
This study's enrollment of 91 is below the median of 400 across 66 observational studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →WellSpan Health is the lead sponsor of 30 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent tissue sampling of any type and received a pathologic diagnosis of endometrial hyperplasia at WellSpan from 2014-2022.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This is the rate of subjects who screen positive for Lynch Syndrome based on immunohistochemical staining
Time frame: 2014-2022
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Colorectal Neoplasms, Hereditary Nonpolyposis →
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