Long-term follow-up for women with simple 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
This study is testing whether giving metformin or no treatment to women with simple hyperplasia without atypia can help prevent the progression to endometrial cancer over the long term.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05292573 on ClinicalTrials.gov |
What this trial studies
This study aims to enroll 1000 women diagnosed with simple hyperplasia or complex hyperplasia without atypia to evaluate the long-term progression to endometrial cancer. Participants will receive education on exercise and weight control and will be randomized to receive either metformin or no intervention. Over three years, the study will analyze various data, including whole genome sequencing and metabolomics, to understand factors influencing cancer progression. An interim analysis will be conducted, with plans for long-term follow-up extending up to 15 years.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 years and older with a histological diagnosis of simple or complex hyperplasia without atypia.
Not a fit: Patients with atypical hyperplasia, endometrial cancer, or other gynecologic cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into preventing the progression of endometrial cancer in women with hyperplasia.
How similar studies have performed: Other studies have shown promise in using metformin for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital, Linkou Branch — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chyong-Huey Lai, M.d.
- Email: laich46@cgmh.org.tw
- Phone: +88633281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.