Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Endometrial Hyperplasia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension
排除标准
- •Women who have had a hysterectomy
结局指标
主要结局
Endometrial Hyperplasia
时间窗: 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.
次要结局
- Endometrial Cancer(End of study)
研究者
Richard S. Legro, M.D.
Professor, Obstetrics and Gynecology and Public Health Sciences
Milton S. Hershey Medical Center