Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort
The objective is to identify the utility of ultrasound as a screening test for endometrial
hyperplasia and cancer in an "at risk" cohort. Endometrial carcinoma is an understudied
cancer. This study will provide benefit regardless of its outcome, because it will be the
first prospectively designed screening trial in an asymptomatic population.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
A transvaginal ultrasound of the endometrium will be performed to obtain measures of the anteroposterior endometrial thickness (in the sagittal plane), the dimensions of the endometrial cavity (thickness, length and width), and the appearance of the endometrium in addition to uterine and ovarian measures. Endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with the metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.
End of study
Richard Legro, M.D.
Penn State College of Medicine
United States: Institutional Review Board
|Penn State Milton S. Hershey||Hershey, Pennsylvania 17033|