Screening for Endometrial Abnormalities in Overweight and Obese Women

NCT ID: NCT01922778

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endometrial Biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Roosevelt

Locations

Mount Sinai Roosevelt

New York, New York, United States

Countries

United States

Other Identifiers

13-0105

Identifier Type: -

Identifier Source: org_study_id