Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia (NCT05292573) | Clinical Trial Compass
UnknownPhase 3
Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
Taiwan1,000 participantsStarted 2018-08-01
Plain-language 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.
Who can participate
Age range20 Years
SexFEMALE
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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
What they're measuring
1
The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 3 miRs.