A Phase 3 interventional study of Metformin in Female, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Health services research
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.
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.
103 studies on the registry are indexed under Endometrial Hyperplasia; 35 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 76 across 66 interventional studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Metformin
only exercise and weight control to all eligible participants
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.
Also known as: Uformin Tablet 500mg
The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.
The primary endpoint of the randomized prospective study is to evaluate the ROC of the prediction miR panel of the 3 miRs.
Time frame: 5 years
Time to progression among groups
Incidence of progression to endometrial cancer among groups, Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 years
Subgroup analysis in body-weight control
Follow up the body-weight control
Time frame: 3 years
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Chang Gung Memorial Hospital