Clinical trial · Interventional
Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (SH/CH) without atypia. All subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. At the end of this 3-year project, an interim analysis will be performed. Since long-term follow-up is intended, therefore for the 4th to 6th year a new grant support will be looked for. The long-term occurrence of endometrial cancer (up to15 years) data will be acquired from national cancer registry, which permission is addressed in the informed sent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- metformin group
- description
- 1. During the intervention period, metformin is given 500 mg tablet b.i.d. 2. We will deliver education for exercise and weight control to all eligible participants
- interventionNames
- Drug: Metformin
- type
- NO_INTERVENTION
- label
- Observation group
- description
- only exercise and weight control to all eligible participants
Primary outcomes (1)
- measure
- The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.
- timeFrame
- 5 years
- description
- The primary endpoint of the randomized prospective study is to evaluate the ROC of the prediction miR panel of the 3 miRs.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged ≧ 20 years 2. Histological diagnosis of SH/CH without atypia 3. Not taking Metformin for diabetes mellitus currently 4. Adequate kidney function 5. Provided informed consent within 3 months of diagnosis 6. No previous history of breast cancer with tamoxifen use 7. Willing to be followed for 5 years Exclusion Criteria: 1. Atypical hyperplasia or EC found within 3 months after enrollment 2. History or concurrent gynecologic cancers or cervical intraepithelial neoplasia 3. Pregnancy test positive 4. History of intolerance to Metformin 5. Family history of HNPCC
References
Publications (0)
Data not yet available