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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473186
First Posted: November 17, 2011
Last Update Posted: June 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Susan Modesitt, MD, University of Virginia
  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 Susan Modesitt, MD, University of Virginia:

Biospecimen Retention:   Samples With DNA
blood, omentum, endometrium, adipose tissue

Estimated Enrollment: 100
Study Start Date: January 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
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): NCT01473186


Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Susan Modesitt, MD University of Virginia
  More Information

Responsible Party: Susan Modesitt, MD, Attending, University of Virginia
ClinicalTrials.gov Identifier: NCT01473186     History of Changes
Other Study ID Numbers: 15116
First Submitted: November 14, 2011
First Posted: November 17, 2011
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by Susan Modesitt, MD, University of Virginia:
morbid obesity
endometrial pathology
menstrual irregularities

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