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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00495235
First received: July 2, 2007
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Endometrial Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Prevalence Rate of Insulin Resistance [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sample and, if diagnosed with endometrial cancer and had surgical removal of uterus, a piece of leftover tumor and surrounding normal tissue will be tested for markers of insulin resistance and PCOS.


Enrollment: 147
Study Start Date: October 2005
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Endometrial Cancer Group
Participants who have had endometrial cancer (cases).
Behavioral: Questionnaire
Questionnaire taking about 20 minutes to complete.
Other Name: Survey
Control Group
Participants who have not had endometrial cancer (controls).
Behavioral: Questionnaire
Questionnaire taking about 20 minutes to complete.
Other Name: Survey

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495235

Locations
United States, Texas
Baylor College of Medicine/Clinics
Houston, Texas, United States, 77030
Ben Taub Hospital
Houston, Texas, United States, 77030
Gynecologic Oncology of Houston
Houston, Texas, United States, 77030
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
The Woman's Hospital of Texas
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00495235     History of Changes
Other Study ID Numbers: 2005-0164
Study First Received: July 2, 2007
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Endometrial Cancer
Polycystic Ovarian Syndrome
Insulin Resistance
Pre-diabetes
Harris County
PCOS
Uterus
Questionnaire
Body mass index
BMI

Additional relevant MeSH terms:
Endometrial Neoplasms
Insulin Resistance
Genital Diseases, Female
Genital Neoplasms, Female
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014