Prevalence of Endometrial Abnormalities In Obese Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 30 - 55 |
| Updated: | 12/2/2018 |
| Start Date: | June 2004 |
| End Date: | June 2019 |
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.
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.
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.
Inclusion Criteria:
1. Patients must have a measured BMI greater than or equal to 30 kg/m2 (obese) or less
than or equal to 25 kg/m2 (lean) at the time of enrollment.
2. Patients must be between the ages of 30 and 55 years old at the time of enrollment.
3. Patients must not have taken any birth control (including pills, patch, injectables)
for at least three months prior to enrollment.
4. Patients may not be pregnant at the time of enrollment (defined by negative urine
pregnancy test).
5. Patients must have signed an informed consent indicating they are aware of the
investigational nature of this study.
6. Patients with a history of non-metastatic cancer may be included if they have not
undergone cancer treatment for at least six months prior to enrollment.
Exclusion Criteria:
1. Patients who have had a prior hysterectomy.
2. Patients who are pregnant or have a positive pregnancy test.
3. Patients with a prior history of endometrial hyperplasia or endometrial cancer.
4. Patients who are currently on birth control (including pills, patch, or injectable
birth control).
5. Patients who are postmenopausal (have not had a menstrual cycle in greater than or
equal to one year).
6. Patients who have ever been on selective estrogen receptor modulators (SERMs) in the
past including Tamoxifen and Raloxifene.
7. Patients with a history of metastatic cancer (any type).
8. Patients with a history of non-metastatic cancer who are currently undergoing therapy
for that cancer or who have received therapy within six months of enrollment.
9. Patients with a history of non-metastatic cancer who have received any type of
hormonal therapy including but not limited to aromatase inhibitors, GNRH-agonists, and
Zoladex.
10. Patients who have had prior radiation to the pelvis.
11. Patients with psychiatric disorders that would interfere with consent.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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