Brief Title
Screening for Endometrial Abnormalities in Overweight and Obese Women
Official Title
Screening for Endometrial Abnormalities in Overweight and Obese Women
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.
Study Type
Interventional
Primary Outcome
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
Condition
Endometrial Cancer
Intervention
Endometrial Biopsy
Study Arms / Comparison Groups
Endometrial Biopsy
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
303
Start Date
September 2013
Completion Date
March 31, 2016
Primary Completion Date
March 31, 2016
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
Gender
Female
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Lisa Anderson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01922778
Organization ID
13-0105
Responsible Party
Sponsor
Study Sponsor
St. Luke's-Roosevelt Hospital Center
Study Sponsor
Lisa Anderson, MD, Principal Investigator, Mount Sinai Roosevelt
Verification Date
July 2017