Back to resultsScreening for Endometrial Abnormalities in Overweight and Obese Women
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endometrial Biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
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
Sites / Locations
- Mount Sinai Roosevelt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endometrial Biopsy
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01922778
First Posted
August 8, 2013
Last Updated
July 19, 2017
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT01922778
Brief Title
Screening for Endometrial Abnormalities in Overweight and Obese Women
Official Title
Screening for Endometrial Abnormalities in Overweight and Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial Biopsy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Endometrial Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Anderson, MD
Organizational Affiliation
Mount Sinai Roosevelt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Screening for Endometrial Abnormalities in Overweight and Obese Women
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