Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

Female Clinical Trial

Official title:

MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292573
• Other study ID #: 107-2314-B-182A-166-MY3
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2018
• Est. completion date: January 29, 2026

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: CHYONG-HUEY LAI, M.D.
• Phone: +88633281200
• Email: laich46[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 29, 2026
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Female
• Hyperplasia

Intervention

Drug:
• Metformin
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	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	3 years
Secondary	Subgroup analysis in body-weight control	Follow up the body-weight control	3 years