Endometrial Hyperplasia
Conditions
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.
Interventions
PROCEDUREUltrasound and Biopsy
Transvaginal ultrasound and Endometrial Biopsy
Sponsors
Center for Research on Women and Health
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension
Exclusion criteria
* Women who have had a hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed