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

May 20, 2014 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants from Harris County who have had endometrial cancer (cases) and those who have not (controls).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometrial Cancer Group
Participants who have had endometrial cancer (cases).
Behavioral: Questionnaire
Questionnaire taking about 20 minutes to complete.
Other Names:
  • Survey
Control Group
Participants who have not had endometrial cancer (controls).
Behavioral: Questionnaire
Questionnaire taking about 20 minutes to complete.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence Rate of Insulin Resistance
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Karen H. Lu, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 2, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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