Screening for Endometrial Abnormalities in Overweight and Obese Women

NCT01922778 | Completed DMC

• 1 other identifier: 13-0105
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Endometrial Biopsy

EXPERIMENTAL

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

Interventions

Endometrial Biopsy 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.

Endometrial Biopsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

Mount Sinai Roosevelt

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lisa Anderson, MD

  Mount Sinai Roosevelt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 14, 2013
• Study Start: September 1, 2013
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)