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Screening for Endometrial Abnormalities in Overweight and Obese Women

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ClinicalTrials.gov Identifier: NCT01922778
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Endometrial Biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Screening for Endometrial Abnormalities in Overweight and Obese Women
Study Start Date : September 2013
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: 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.

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.





Primary Outcome Measures :
  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 [ Time Frame: up to 1 year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922778


Locations
United States, New York
Mount Sinai Roosevelt
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Lisa Anderson, MD Mount Sinai Roosevelt

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01922778     History of Changes
Other Study ID Numbers: 13-0105
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Overweight
Body Weight
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female