Screening for Endometrial Abnormalities in Overweight and Obese Women

St. Luke's-Roosevelt Hospital Center

Status: Completed

Conditions: Endometrial Cancer

Treatments: Procedure: Endometrial Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01922778

13-0105

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have BMI ≥25.
• Be patients of the St. Luke's and Roosevelt Gynecology Clinics and Faculty Practices OR be receiving bariatric surgery.
• Complete a full medical history, a detailed menstrual and/or postmenopausal bleeding history, and endometrial biopsy.
• Have a negative pregnancy test, if of childbearing age.
• Be at least 18 years of age.
• Have signed a written Informed Consent Document.
• Be willing and able to comply with the study requirements.

Exclusion criteria

• Have a BMI <25.
• Have a prior hysterectomy.
• Be pregnant or have a positive pregnancy test
• Have untreated vaginal, cervical, or adnexal infection.
• Recent treatment of STD

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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303 participants in 1 patient group

Endometrial Biopsy

Experimental group

Description:

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.

Treatment:

Procedure: Endometrial Biopsy