Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

Phase 3

Recruiting

• Conditions: Female
• Interventions: Drug: Metformin

• Registration Number: NCT05292573
• Lead Sponsor: Chang Gung Memorial Hospital

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 Timeline

• Study Start: 2018-08-01
• Status Verified: 2021-07
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-23
• Last Update Posted: 2022-03-23
• Primary Completion: 2022-10-01
• Study Completion: 2026-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin group	Metformin	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Linkou Branch; 🇨🇳 Taoyuan, Taiwan