Clinical trial NCT05292573: Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
Official title: MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Female
Keywords: simple hyperplasia
Metformain
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.
timeFrame: 5 years
Secondary outcomes:
measure: Time to progression among groups
timeFrame: 3 years
measure: Subgroup analysis in body-weight control
timeFrame: 3 years
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou Branch
Study officials:
References: