Endometrial NeoplasmsNCT07114653
The Role of POLE Mutation in High Risk Endometrial Cancer.
An observational study of Endometrial Neoplasms, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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? Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Neoplasms
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All high-risk endometrial cancer cases
Who may be able to join
- women with high-risk for recurrent endometrial cancer
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, MD, +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
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?
Read the 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?
- Conditions
- Endometrial Neoplasms
- Keywords
- Endometrial cancer, POLE mutation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endometrial cancer | high-risk for reurrence of endometrial cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of POLE mutation in high risk endometrial cancer
The prevalence of POLE mutations in women with high-risk for recurrent endometrial cancer
Measured: 2 years
Secondary outcomes (1)
The impact of POLE on overall survival
The impact of POLE on overall survival, compared with the other TCGA groups
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114653
- Sponsor's protocol ID
- 113298-E
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of POLE Mutation in High Risk Endometrial Cancer.
- ClinicalTrials.gov ID
- NCT07114653
- Acronym / sponsor ID
- 113298-E
- Conditions
- Endometrial Neoplasms
- Keywords
- Endometrial cancer, POLE mutation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrial cancer | – | –high-risk for reurrence of endometrial cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All high-risk endometrial cancer cases
Key inclusion criteria (1 listed)
- women with high-risk for recurrent endometrial cancer
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of POLE mutation in high risk endometrial cancer
Time frame: 2 years
The prevalence of POLE mutations in women with high-risk for recurrent endometrial cancer
1 secondary outcome
The impact of POLE on overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of POLE mutation in high risk endometrial cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.