Prevalence of Endometrial Abnormalities In Obese Women
It is known that women who are obese are at higher risk of endometrial cancer (cancer of the lining of the uterus or womb). The goal of this clinical research study is to find out how common abnormalities of the endometrium are in women who are considered obese and to find out if those same abnormalities are less common in women who are considered to be thin. Researchers would like to learn if obese patients have symptoms (like irregular menstrual cycles) that may mean there could be an abnormality present. Researchers would also like to know if obese women have access to regular female exams and whether they routinely go to their primary care doctors.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prevalence of Endometrial Abnormalities In Obese Women|
- Prevalence of Endometrial Abnormalities in Obese and Lean Women [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples used to look at different hormone levels related to risk of endometrial abnormalities. An endometrial biopsy will be performed to collect a tissue sample.
|Study Start Date:||June 2004|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Questionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes.
Other Name: Survey
Women in this study will be asked to complete three different parts of the study. All three parts of the study will be done during one visit to the gynecology center. First, you will be asked to complete a survey/questionnaire that will give researchers information on your background, weight history, gynecologic, and medical history. You will be assisted by a research nurse and completion of the questionnaire is expected take about 30 minutes.
Second, you will be asked to have a blood sample drawn. About 2 tablespoons of blood will be drawn. This blood will be used to look at different hormone levels that may be related to your risk of endometrial abnormalities.
Third, an endometrial biopsy will be performed by one of the doctors running the study. This will require you to have a full pelvic exam (much like when you have a pap smear), which will include looking at the cervix (mouth of the womb) and putting a small pipelle (straw) into the womb to collect a tissue sample. This procedure is routinely done in the office. You will not be required to take medications prior to the procedure and you will not receive a prescription for pain medication once the procedure is complete.
Completion of all three parts of the study may take between one to two hours. You and your physician will be notified of your endometrial biopsy results.
This is an investigational study. Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500591
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Karen H. Lu, MD||M.D. Anderson Cancer Center|