The Role of POLE Mutation in High Risk Endometrial Cancer. | NCT07114653

Studies
The Role of POLE Mutation in High Risk Endometrial Cancer.

NCT07114653

Sponsor

Far Eastern Memorial Hospital

Status

Recruiting

Last Update Posted

Aug 11, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Endometrial Neoplasms

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Aug 4, 2025

First Submission Date that Met QC Criteria

Aug 4, 2025

First Posted Date

Aug 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2025

Last Update Posted Date

Aug 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

All high-risk recurrent endometrial cancer cases who were treated in a tertiary referral center will be analyzed and subjected to POLE mutation analysis. In addition, survival analysis will be used to analyze the role of POLE mutations in women with high-risk endometrial cancer. We can answers the following.

What is the prevalence of POLE mutations in women with high-risk endometrial cancer?
What is the role of POLE mutations in real world high-risk endometrial cancer?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
endometrial cancer		high-risk for reurrence of endometrial cancer.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The impact of POLE on overall survival	The impact of POLE on overall survival, compared with the other TCGA groups	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with high-risk for recurrent endometrial cancer

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with high-risk endometrial cancer

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All high-risk endometrial cancer cases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Recruiting	Banqiao District	New Taipei	22050	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

Not provided