Screening for Endometrial Abnormalities in Overweight and Obese Women

Study Overview
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Brief Summary
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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.

Official Title
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Screening for Endometrial Abnormalities in Overweight and Obese Women

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: Endometrial Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial Biopsy<br>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. | Procedure: Endometrial Biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | up to 1 year |