Clinical Trial: Ultrasound and Endometrial Hyperplasia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Milton S. Hershey Medical Center

Current Primary Outcome: Endometrial Hyperplasia [ Time Frame: End of study ]

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.


Original Primary Outcome: Our objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an "at risk" cohort.

Current Secondary Outcome: Endometrial Cancer [ Time Frame: End of study ]

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.


Original Secondary Outcome: We propose that this metabolic syndrome is also a risk factor for endometrial hyperplasia and cancer.

Information By: Milton S. Hershey Medical Center

Dates:
Date Received: July 20, 2005
Date Started: April 2005
Date Completion:
Last Updated: January 16, 2015
Last Verified: January 2015