NCT01922778

Screening for Endometrial Abnormalities in Overweight and Obese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: St. Luke's-Roosevelt Hospital Center · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	Endometrial Biopsy	Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. During the interview, the purpose of the study will be explained as well as the surgical technique used for obtaining an endometrial sample. 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 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 using an endometrial suction catheter.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-03-31
• Completion: 2016-03-31
• First posted: 2013-08-14
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States