Status:
RECRUITING
Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Female
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
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 ...
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 Healt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05292573
Start Date
August 1 2018
End Date
January 29 2026
Last Update
March 23 2022
Active Locations (1)
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1
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District, Taiwan, 333