Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

  • STATUS
    Recruiting
  • End date
    Jan 29, 2026
  • participants needed
    1000
  • sponsor
    Chang Gung Memorial Hospital
Updated on 11 April 2022

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.

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.

Details
Condition Female
Treatment Metformin
Clinical Study IdentifierNCT05292573
SponsorChang Gung Memorial Hospital
Last Modified on11 April 2022

Eligibility

Yes No Not Sure

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
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