NCT05334303

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

April 7, 2022

Last Update Submit

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

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Zhong-qiu Lin

    Department of Gynecologic Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

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