Ultrasound and Endometrial Hyperplasia

This study has been terminated.
(enrollment of participants has halted prematurely; difficulty with recruitment)
Sponsor:
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
  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:
    Procedure: Ultrasound
    Transvaginal ultrasound and Endometrial Biopsy
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.

  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
Uterine Diseases
Genital Diseases, Female
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014