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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05334303
Collaborator
Presicions Scientific(Beijing) Co., Ltd (Other)
983
24

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We conducted a retrospective real-world study of all endometrial carcinoma cases from 2015 to 2021. The inclusion criterion is all patients diagnosed with endometrial cancer in our hospital from 2015 to 2021 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    983 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Prevalence and Prognostic Impact of Epigenetic MMRd in Endometrial Carcinomas
    Anticipated Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of MMRd caused by MLH1 promoter methylation in endometrial carcinoma [up to two years]

      the prevalence of epigenetic MMRd in endometrial cancer

    Secondary Outcome Measures

    1. progression-free survival time (PFS) [up to two years]

      progression-free survival time (PFS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients diagnosed with endometrial cancer in our hospital from 2015 to 2021
    Exclusion Criteria:
    • those without histological specimens in our hospital

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    • Presicions Scientific(Beijing) Co., Ltd

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05334303
    Other Study ID Numbers:
    • SYSEC-KY-KS-2022-105
    First Posted:
    Apr 19, 2022
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2022