Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 8:29 AM
Study NCT ID:
NCT00495235
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2007-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: