NCT07114653

Brief Summary

The actual role of POLE mutations in high-risk endometrial cancer is undetermined. The main question it aims to answer is: What is the prevalence of POLE mutations in high-risk endometrial cancer case? What is the impact of POLE mutations in real world high-risk endometrial cancer case?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress54%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Endometrial Neoplasms

Keywords

Endometrial cancerPOLE mutation

Outcome Measures

Primary Outcomes (1)

  • Prevalence of POLE mutation in high risk endometrial cancer

    The prevalence of POLE mutations in women with high-risk for recurrent endometrial cancer

    2 years

Secondary Outcomes (1)

  • The impact of POLE on overall survival

    5 years

Study Arms (1)

endometrial cancer

high-risk for reurrence of endometrial cancer.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with high-risk endometrial cancer
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All high-risk endometrial cancer cases

You may qualify if:

  • women with high-risk for recurrent endometrial cancer

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)