Screening for Endometrial Abnormalities in Overweight and Obese Women

Endometrial Cancer Clinical Trial

Official title:

Screening for Endometrial Abnormalities in Overweight and Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922778
• Other study ID #: 13-0105
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: July 19, 2017
• Start date: September 2013
• Est. completion date: March 31, 2016

Study information

• Verified date: July 2017
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Mount Sinai Roosevelt	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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