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Study Summary
No. 2005-0164:.......Endometrial......Karen H. Lu......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:		2005-0164
Study Title:A case-control study of insulin resistance and endometrial cancer in Harris County, Texas
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Physician New Patient Referral
Name:Karen H. LuPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-8902
Contact us about clinical trials
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General Information
Disease Group:EndometrialSupported By:N/A
Phase of Study:N/AReturn
Visit:		N/A
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to find out if there is a link
between insulin resistance (or prediabetes) and endometrial cancer.
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Study Objectives / Outcomes
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.
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Study Status Information
Study Activation / Registration Date:10/27/2005
IRB Review and Approval Date:08/03/2005
Study Type:Cancer Control
Recruitment Status:Open
Projected Accrual:700
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Women with histologically confirmed primary endometrial cancer, who will consent to be enrolled in the study no later than 12 weeks after their primary treament. All stages, grades and histologic subtypes will be eligible.

2) Women who reside in Harris County, Texas. (Cases)

3) Patients must sign an informed consent for the study. (Cases)

4) Women must speak and understand English or Spanish. (Cases)

5) Women who reside in Harris County, Texas. (Controls)

6) No history of prior malignancy with the exception of non-melanoma skin cancer. (Controls)

7) Intact uterus. (Controls)

8) Patients must sign an informed consent for the study. (Controls)

9) Women must speak and understand English or Spanish. (Controls)
Exclusion Criteria:1) Women who reside outside of Harris County, Texas. (Cases)

2) Patients unwilling or unable to provide informed consent. (Cases)

3) Metastatic cancer to the endometrium from a different primary. (Cases)

4) Women who do not speak and understand English or Spanish. (Cases)

5) Women who reside outside of Harris County, Texas. (Controls)

6) Previous hysterectomy. (Controls)

7) History of prior malignancy with the exception of non-melanoma skin cancer. (Controls)

8) Patients unwilling or unable to provide informed consent. (Controls)

9) Women who do not speak and understand English or Spanish. (Controls)
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Links
Registration Number: NCT00495235
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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