Endometrial Cancer Clinical Trial
Official title:
Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas
The goal of this clinical research study is to find out if there is a link between insulin
resistance (or pre-diabetes) and endometrial cancer.
Primary Objective:
1. To determine the association between insulin resistance and endometrial cancer in women
in Harris County, Texas. 2. To assess the effect of body mass index (BMI) on the association
between insulin resistance and endometrial cancer.
Secondary Objectives:
1. To explore the association between polycystic ovarian syndrome (PCOS) and endometrial
cancer.
2. To assess the relationship between known reproductive risk factors, menstrual risk
factors, family history and endometrial cancer.
3. To explore the molecular changes associated with insulin resistance and PCOS on normal
endometrium and tumor tissue.
This study will be comparing women who have had endometrial cancer (cases) to women who have
not had endometrial cancer (controls) in Harris County, Texas to better understand the risk
factors for getting endometrial cancer. Insulin resistance is a condition of pre-diabetes.
Polycystic ovarian syndrome (PCOS) is a condition associated with irregular periods,
obesity, infertility, and/or difficulty in getting pregnant. Both insulin resistance and
PCOS are believed to increase a woman's risk of getting endometrial cancer.
As part of this study, you will be asked to fill out a questionnaire that asks about your
medical history, weight history, family history, reproductive history, and birth
control/hormone use. The questionnaire should take about 20 minutes to complete, and you
will need to complete it only once. You will have your height and weight measured, and about
4 teaspoons of blood will be drawn to test for insulin resistance (or pre-diabetes). You
will be required to fast, not eat or drink anything except water, for 8 hours before having
this blood sample drawn. If you are premenopausal and still have both your ovaries, you will
have an additional 4 teaspoons of blood drawn to test for PCOS. You will complete the
questionnaire during your first visit or at home and will bring it back with you when you
come back for your fasting blood test appointment.
If you have been diagnosed with endometrial cancer and have had surgery to remove your
uterus, you will also be asked to give permission to use a piece of your leftover tumor and
surrounding normal tissue to test for markers of insulin resistance and PCOS. This will be
from tissue that was removed during your surgery and will not require another biopsy or
surgery.
You will not be required to come back for any follow-up as part of this study. However, you
will be asked to fill out a form that asks if you would be willing to be called in the
future to participate in other studies.
This is an investigational study. A total of 700 women will take part in this multicenter
study, 350 women with endometrial cancer and 350 women without endometrial cancer. A total
of up to 350 women will be enrolled at M.D. Anderson.
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Observational Model: Case Control, Time Perspective: Prospective
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