MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.
Study Overview
Brief Summary
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.
Detailed Description
The first year: (1) the cumulative progression rate of SH/CH without atypia to endometrial cancer (EC) of the 1989-2011 cohort will be investigated by linking with national health databases from Health and Welfare Data Science Center (HWDC); (2) Prospectively enroll 200 patients with SH/CH without atypia and deliver education for exercise and weight control and collect the related biospecimens and data; (3) 1:1 randomized to with or without metformin intervention.
The 2nd year: (1) analyze the whole genome sequencing (WGS) data of those progressed and non-progressed ; (2) analyze the metabolomic data in relation to exercise and weight control data.
The 3rd year: (1) validate microRNA (miR) panel in tissues and sera selected by CMRPG3G1511-3; (2) analyze data of MiR panel, degree of exercise/weight control, clinical lab data, and demographic data on EC progression rate; (3) Incremental predicting proficiency of the model including metabolomics data and WGS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged ≧ 20 years
- •Histological diagnosis of SH/CH without atypia
- •Not taking Metformin for diabetes mellitus currently
- •Adequate kidney function
- •Provided informed consent within 3 months of diagnosis
- •No previous history of breast cancer with tamoxifen use
- •Willing to be followed for 5 years
Exclusion Criteria
- •Atypical hyperplasia or EC found within 3 months after enrollment
- •History or concurrent gynecologic cancers or cervical intraepithelial neoplasia
- •Pregnancy test positive
- •History of intolerance to Metformin
- •Family history of HNPCC
Arms & Interventions
metformin group
- During the intervention period, metformin is given 500 mg tablet b.i.d.
- We will deliver education for exercise and weight control to all eligible participants
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.
Time Frame: 5 years
The primary endpoint of the randomized prospective study is to evaluate the ROC of the prediction miR panel of the 3 miRs.
Secondary Outcomes
- Time to progression among groups(3 years)
- Subgroup analysis in body-weight control(3 years)