Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese Women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Questionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Endometrial Abnormalities in Obese and Lean Women | 6 Years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Study participants with a measured BMI greater than or equal to 30 kg/m^2 (obese) or less than or equal to 25 kg/m^2 (lean) at the time of enrollment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen H. Lu, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32835719 | Derived | Dottino JA, Zhang Q, Loose DS, Fellman B, Melendez BD, Borthwick MS, McKenzie LJ, Yuan Y, Yang RK, Broaddus RR, Lu KH, Soliman PT, Yates MS. Endometrial biomarkers in premenopausal women with obesity: an at-risk cohort. Am J Obstet Gynecol. 2021 Mar;224(3):278.e1-278.e14. doi: 10.1016/j.ajog.2020.08.053. Epub 2020 Aug 21. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |