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NCT01473186 · ClinicalTrials.gov registry record
Study of Menstrual Irregularities and Endometrial Pathology in Women Undergoing Bariatric Surgery
A clinical trial, sponsored by University of Virginia.
- Completed
- Registry status
- 100
- Enrollment target
NCT01473186 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 100 participants.
The verdict
NCT01473186 has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
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 wome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01473186
The ClinicalTrials.gov registry entry for NCT01473186 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01473186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01473186 about?
NCT01473186 is a clinical study titled "Study of Menstrual Irregularities and Endometrial Pathology in Women Undergoing Bariatric Surgery". 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 ide...
What is the current status of trial NCT01473186?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2011-01. Estimated completion is 2015-01.
Who is sponsoring clinical trial NCT01473186?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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