Ultrasound and Endometrial Hyperplasia

Not Applicable

Terminated

• Conditions: Endometrial Hyperplasia
• Interventions: Procedure: Ultrasound and Biopsy

• Registration Number: NCT00123188
• Lead Sponsor: Milton S. Hershey Medical Center

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 Description

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension

Exclusion Criteria

• Women who have had a hysterectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound and Biopsy	Ultrasound and Biopsy	Transvaginal Ultrasound and Endometrial Biopsy

Primary Outcome Measures

Name	Time	Method
Endometrial Hyperplasia	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.

Secondary Outcome Measures

Name	Time	Method
Endometrial Cancer	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.

Trial Locations

Locations (1)

Penn State Milton S. Hershey; 🇺🇸 Hershey, Pennsylvania, United States