The Impact of Epigenetic MMRd in Endometrial carcinomas-a Real World Study
Prevalence and Prognostic Impact of Epigenetic MMRd in Endometrial Carcinomas
1 other identifier
observational
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedStudy Start
First participant enrolled
November 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedNovember 21, 2022
March 1, 2022
1.5 years
April 7, 2022
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of MMRd caused by MLH1 promoter methylation in endometrial carcinoma
the prevalence of epigenetic MMRd in endometrial cancer
up to two years
Secondary Outcomes (1)
progression-free survival time (PFS)
up to two years
Study Arms (3)
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
Eligibility Criteria
Patients with histologically confirmed endometrial carcinoma and case slides available for review from 2019 to 2022 in our hospital.
You may qualify if:
- all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022
You may not qualify if:
- those without histological specimens in our hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhong-qiu Lin
Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 19, 2022
Study Start
November 17, 2022
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
November 21, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share