Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

Chang Gung Medical Foundation

Status and phase: Enrolling; Phase 3

Conditions: Female

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05292573

107-2314-B-182A-166-MY3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

metformin group

Experimental group

Description:

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

Treatment:

Drug: Metformin

Observation group

No Intervention group

Description:

only exercise and weight control to all eligible participants