We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Frequency of Endometrial Cancer Precursors Associated With Lynch Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05257057
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Eav Lim, WellSpan Health

Brief 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.


Condition or disease Intervention/treatment
Lynch Syndrome Endometrial Cancer Endometrial Hyperplasia Mismatch Repair Deficiency Microsatellite Instability Diagnostic Test: Immunohistochemical staining

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
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


Group/Cohort Intervention/treatment
Endometrial hyperplasia
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




Primary Outcome Measures :
  1. 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
No new biospecimens are retained. The biospecimens referenced are those that were already collected for tissue diagnosis of endometrial hyperplasia: endometrial biopsies, curettage specimens, and hysterectomy specimens. These are kept routinely in the pathology department on microscope slides post-procedure per hospital policy.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent tissue sampling of any type and received a pathologic diagnosis of endometrial hyperplasia at WellSpan from 2014-2022.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Eav Lim, DO (717) 851-6120 elim@wellspan.org
Contact: Kathryn Kennedy, MD 7178516120 kkennedy15@wellspan.org

Locations
Layout table for location information
United States, Pennsylvania
WellSpan Recruiting
York, Pennsylvania, United States, 17403
Contact: Eav Lim, DO    717-741-8100    elim@wellspan.org   
Sponsors and Collaborators
WellSpan Health
Investigators
Layout table for investigator information
Principal Investigator: Eav Lim, DO WellSpan Health-York Cancer Center
Publications:

Layout table for additonal information
Responsible Party: Eav Lim, Principal Investigator, WellSpan Health
ClinicalTrials.gov Identifier: NCT05257057    
Other Study ID Numbers: 1403922-5
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eav Lim, WellSpan Health:
Lynch Syndrome
endometrial hyperplasia
endometrial cancer
immunohistochemistry
mismatch repair
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Endometrial Hyperplasia
Syndrome
Hyperplasia
Microsatellite Instability
Disease
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Genomic Instability