Ultrasound and Endometrial Hyperplasia
The investigators hypothesize that endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort|
- Endometrial Hyperplasia [ Time Frame: End of study ] [ Designated as safety issue: No ]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.
- Endometrial Cancer [ Time Frame: End of study ] [ Designated as safety issue: No ]All women will then undergo an endometrial biopsy. The pipelle has been shown to be an accurate method of diagnosing endometrial cancer comparable to a full dilatation and curettage of the uterus. We believe it is important to perform a biopsy even in women with a thin endometrial stripe (<5mm), as it will be important for determining the specificity and negative predictive value of both ultrasound and any serum screening strategy we devise.
|Study Start Date:||April 2005|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Ultrasound and Biopsy
Transvaginal Ultrasound and Endometrial Biopsy
Procedure: Ultrasound and Biopsy
Transvaginal ultrasound and Endometrial Biopsy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123188
|United States, Pennsylvania|
|Penn State Milton S. Hershey|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Richard Legro, M.D.||Penn State College of Medicine|