Study of Menstrual Irregularities and Endometrial Pathology in Women Undergoing Bariatric Surgery

This study is currently recruiting participants.
Verified December 2013 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Susan Modesitt, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01473186
First received: November 14, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Objectives: Given the profound impact of obesity on the genesis of endometrial cancer, this study proposes to prospectively evaluate the baseline prevalence of menstrual irregularities and endometrial pathology in morbidly obese women and discover risk stratification markers that can potentially identify the highest risk women who might benefit from targeted cancer prevention strategies in a future clinical trial.

  • Specific Aim 1: To assess the prevalence of menstrual irregularities and to correlate gynecologic and menstrual history with the perceived personal risk and severity of gynecologic cancers in a population of female bariatric surgery candidates.
  • Specific Aim 2: To determine the prevalence of endometrial hyperplasia and cancer in morbidly obese women undergoing bariatric surgery.
  • Specific Aim 3: To obtain adipose, endometrium, and blood samples (before and after) bariatric surgery to assess baseline hormone levels and adipocyte-derived factors and to correlate with presence of menstrual irregularities, endometrial hyperplasia or cancer, and with postsurgical weight changes.

Methods:

  • Specific Aim 1: After informed consent is obtained, a survey and medical history of prospective bariatric surgery patients will be performed at the University of Virginia.
  • Specific Aim 2: For those women who undergo bariatric surgery, study investigators will perform endometrial biopsies at the time of bariatric surgery on participants to determine the status of the endometrial lining and the potential presence of endometrial cancer and its precursors.
  • Specific Aim 3: At the time of surgery, blood, adipose, and endometrial tissue samples will collected for evaluation of adipocyte-related factors and correlation with clinical endpoints. Blood will also be collected at 6 and 12 months after surgery.

Anticipated results: This study will identify the prevalence and correlation of menstrual irregularities with endometrial abnormalities and cancer in morbidly obese women as well as define their perceived risk of developing cancer. Serum biomarkers in obese women with and without endometrial cancer/precancer would be evaluated for correlation and potential applicability for endometrial cancer screening in this high-risk population. Most importantly, this study may provide evidence as to whether screening (via endometrial biopsy or other serum markers) is warranted in asymptomatic, morbidly obese women and suggest potential preventive and risk reduction mechanisms.


Condition
Morbid Obesity
Endometrial Pathology
Menstrual Irregularities

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Menstrual Irregularities and Endometrial Pathology in Women Who Are Candidates for Bariatric Surgery: Correlation With Perceived Risk, Biomarkers, and Weight Loss

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Biospecimen Retention:   Samples With DNA

blood, omentum, endometrium, adipose tissue


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who are candidates for bariatric surgery at the University of Virginia Center of Digestive health who are 18 or older

Criteria

Inclusion Criteria:

  • 18 or older
  • female gender

Exclusion Criteria:

  • male gender
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473186

Contacts
Contact: Sanja Arapovic, MS 434-924-2745 SU2X@virginia.edu
Contact: Heather Lothamer, MSN 434-924-9924 hll5y@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Heather L Lothamer, MSN    434-924-9924    hll5y@virginia.edu   
Principal Investigator: Susan C Modesitt, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Susan Modesitt, MD University of Virginia
  More Information

No publications provided

Responsible Party: Susan Modesitt, MD, Attending, University of Virginia
ClinicalTrials.gov Identifier: NCT01473186     History of Changes
Other Study ID Numbers: 15116
Study First Received: November 14, 2011
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
morbid obesity
endometrial pathology
menstrual irregularities

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014