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Tracking Information | |||||
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First Received Date † | July 2, 2007 | ||||
Last Updated Date | March 2, 2009 | ||||
Start Date † | October 2005 | ||||
Current Primary Outcome Measures † |
To find out if there is a link between insulin resistance (or pre-diabetes) and endometrial cancer. [ Time Frame: 5 Years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00495235 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas | ||||
Official Title † | Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas | ||||
Brief Summary | Primary Objective:
Secondary Objectives:
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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. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Case Control, Prospective | ||||
Condition † | Endometrial Cancer | ||||
Intervention † | Behavioral: Questionnaire | ||||
Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 700 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00495235 | ||||
Responsible Party | Karen H. Lu, MD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | M.D. Anderson Cancer Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |