Female
Conditions
Keywords
simple hyperplasia, Metformain
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.
Interventions
DRUGMetformin
During the intervention period, metformin is given 500 mg tablet b.i.d. Those who stopped taking metformin will remain in the study not counting as protocol violation.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs. | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to progression among groups | 3 years | Incidence of progression to endometrial cancer among groups, Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Subgroup analysis in body-weight control | 3 years | Follow up the body-weight control |
Countries
Taiwan
Contacts
Primary ContactCHYONG-HUEY LAI, M.D.
Outcome results
None listed