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临床试验/NCT01922778
NCT01922778已完成不适用

Screening for Endometrial Abnormalities in Overweight and Obese Women

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
303
试验地点
1
主要终点
A BMI cut-point will be identified at and above which an endometrial biopsy yields optimal sensitivity, specificity, positive predictive value, and negative predictive value to screen for endometrial cancer and abnormal pathologies

研究概览

简要总结

The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women.

There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Endometrial Biopsy

Experimental

Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. If the patient consents to the procedure, then this will usually be a D&C performed in one setting at the time of her bariatric surgery under general anesthesia. In the case where a patient is diagnosed with complex atypical endometrial hyperplasia or early endometrial prior to her bariatric surgery, an IUD device can be inserted at the time of her bariatric surgery.

For patients not undergoing bariatric surgery, an endometrial biopsy will be performed in the clinic or office setting. If the biopsy cannot be performed due to technical difficulty (cervical stenosis) or inadequate sampling, we will try again on a different day after a trial of vaginal misoprostol (Cytotec) 400 or 600 mcg per vagina the night before.

干预措施: Endometrial Biopsy (Procedure)

结局指标

主要结局

A BMI cut-point will be identified at and above which an endometrial biopsy yields optimal sensitivity, specificity, positive predictive value, and negative predictive value to screen for endometrial cancer and abnormal pathologies

时间窗: up to 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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