Ultrasound and Endometrial Hyperplasia
This study has been terminated.
(enrollment of participants has halted prematurely; difficulty with recruitment)
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
Center for Research on Women and Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00123188
First received: July 20, 2005
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Hyperplasia |
Procedure: Ultrasound |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
Resource links provided by NLM:
Further study details as provided by Milton S. Hershey Medical Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 36 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Ultrasound
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.
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension
Exclusion Criteria:
- Women who have had a hysterectomy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123188
Locations
| United States, Pennsylvania | |
| Penn State Milton S. Hershey | |
| Hershey, Pennsylvania, United States, 17033 | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Center for Research on Women and Health
Investigators
| Principal Investigator: | Richard Legro, M.D. | Penn State College of Medicine |
More Information
No publications provided
| Responsible Party: | Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00123188 History of Changes |
| Other Study ID Numbers: | 20175 |
| Study First Received: | July 20, 2005 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Endometrial Hyperplasia Hyperplasia Adenoma Uterine Diseases Genital Diseases, Female |
Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013