Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
NCT ID: NCT05292573
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2018-08-01
2026-01-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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metformin group
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
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.
Observation group
only exercise and weight control to all eligible participants
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
FEMALE
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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107-2314-B-182A-166-MY3
Identifier Type: -
Identifier Source: org_study_id
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