Back to resultsUltrasound and Endometrial Hyperplasia
Primary Purpose
Endometrial Hyperplasia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound and Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Hyperplasia
Eligibility Criteria
Inclusion Criteria: Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension Exclusion Criteria: Women who have had a hysterectomy
Sites / Locations
- Penn State Milton S. Hershey
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound and Biopsy
Arm Description
Transvaginal Ultrasound and Endometrial Biopsy
Outcomes
Primary Outcome Measures
Endometrial Hyperplasia
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
Endometrial Cancer
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.
Full Information
NCT ID
NCT00123188
First Posted
July 20, 2005
Last Updated
January 16, 2015
Sponsor
Milton S. Hershey Medical Center
Collaborators
Center for Research on Women and Health
1. Study Identification
Unique Protocol Identification Number
NCT00123188
Brief Title
Ultrasound and Endometrial Hyperplasia
Official Title
Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
enrollment of participants has halted prematurely; difficulty with recruitment
Study Start Date
April 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Center for Research on Women and Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound and Biopsy
Arm Type
Experimental
Arm Description
Transvaginal Ultrasound and Endometrial Biopsy
Intervention Type
Procedure
Intervention Name(s)
Ultrasound and Biopsy
Intervention Description
Transvaginal ultrasound and Endometrial Biopsy
Primary Outcome Measure Information:
Title
Endometrial Hyperplasia
Description
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.
Time Frame
End of study
Secondary Outcome Measure Information:
Title
Endometrial Cancer
Description
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.
Time Frame
End of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension
Exclusion Criteria:
Women who have had a hysterectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Legro, M.D.
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ultrasound and Endometrial Hyperplasia
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