The Impact of Epigenetic MMRd in Endometrial carcinomas-a Real World Study

November 17, 2022 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Prevalence and Prognostic Impact of Epigenetic MMRd in Endometrial Carcinomas

In recent years, the incidence of endometrial carcinoma (EC) has increased significantly and patients tends to be younger. In addition to known risk factors such as obesity, hypertension and diabetes, genetic factors also play an important role in the occurrence and development of EC. Among them, Mismatch Repair Defect (MMR) can produce mutant phenotypes, leading to cancer susceptibility. Although some articles indicated that epigenetic MMRd, one type of MMRd, predicted poor prognosis among endometrial carcinoma patients, hitherto, the clinicopathological significance and prognosis of epigenetic MMRd has not been determined. To date, there are no relevant large-sample data to investigate the prevalence of epigenetic MMRd in Chinese population, as well as the impact on the prognosis of endometrial cancer. In this setting, The purpose of this study was to investigate the prevalence of epigenetic MMRd and its impact on clinicopathology and prognosis on endometrial cancer among Chinese patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

We conducted a retrospective real-world study of all endometrial carcinoma cases from 2019 to 2022. The inclusion criterion is all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022 and exclusion criteria are those without histological specimens in our hospital. After immunohistochemistry and MLH1-promoter methylation testing, tumors were classified into 3 groups according to status of mismatch repair defects. Tumors with MMR abnormalities by IHC and MLH1 methylation were classified as epigenetic MMR deficiency while those without MLH1 methylation were classified as probable MMR mutations, and those without MMRd were classified as MMR proficient. The first outcome is the prevalence of epigenetic MMRd in endometrial cancer, and the second outcome is Whether the clinicopathological features and prognosis of endometrioid adenocarcinoma differ between the epigenetic MMRd population, MMR proficient population and the Lynch/ Lynch-like population.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed endometrial carcinoma and case slides available for review from 2019 to 2022 in our hospital.

Description

Inclusion Criteria:

  • all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022

Exclusion Criteria:

  • those without histological specimens in our hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
epigenetic MMR deficiency
Tumors with MMR abnormalities by IHC and MLH1 methylation
probable MMR mutations
Tumors with MMR abnormalities by IHC and without MLH1 methylation
MMR proficient
without MMR abnormalities by IHC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of MMRd caused by MLH1 promoter methylation in endometrial carcinoma
Time Frame: up to two years
the prevalence of epigenetic MMRd in endometrial cancer
up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival time (PFS)
Time Frame: up to two years
progression-free survival time (PFS)
up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Zhong-qiu Lin, Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 17, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSEC-KY-KS-2022-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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