Screening for Endometrial Abnormalities in Overweight and Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer
• Intervention / Treatment: Procedure: Endometrial Biopsy

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai Roosevelt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endometrial Biopsy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Lisa Anderson, MD, Mount Sinai Roosevelt

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Body Weight; Overweight; Endometrial Neoplasms
• Other Study ID Numbers: 13-0105