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Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas


N/A
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas


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.


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 treatment. 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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Prevalence Rate of Insulin Resistance

Outcome Time Frame:

5 Years

Safety Issue:

No

Principal Investigator

Karen H. Lu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0164

NCT ID:

NCT00495235

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Polycystic Ovarian Syndrome
  • Insulin Resistance
  • Pre-diabetes
  • Harris County
  • PCOS
  • Uterus
  • Questionnaire
  • Body mass index
  • BMI
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Insulin Resistance
  • Adenoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030
The Methodist Hospital Houston, Texas  77030
St. Luke's Episcopal Hospital Houston, Texas  77030
Lyndon B. Johnson General Hospital Houston, Texas  77026-1967
The Woman's Hospital of Texas Houston, Texas  77054
Baylor College of Medicine/Clinics Houston, Texas  77030
Ben Taub Hospital Houston, Texas  77030
Gynecologic Oncology of Houston Houston, Texas  77030