- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123188
Ultrasound and Endometrial Hyperplasia
January 16, 2015 updated by: Richard S. Legro, M.D., Milton S. Hershey Medical Center
Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension
Exclusion Criteria:
- Women who have had a hysterectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultrasound and Biopsy
Transvaginal Ultrasound and Endometrial Biopsy
|
Transvaginal ultrasound and Endometrial Biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
End of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
End of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Legro, M.D., Penn State College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
July 20, 2005
First Submitted That Met QC Criteria
July 21, 2005
First Posted (Estimate)
July 22, 2005
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 16, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20175
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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