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

Completed

Conditions studied: Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT00495235

Run by

M.D. Anderson Cancer Center

People needed

147

Starts

2005-10-01

Last updated by the study team

2014-05-21

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Women who reside in Harris County, Texas. (Cases)
• Patients must sign an informed consent for the study. (Cases)
• Women must speak and understand English or Spanish. (Cases)
• Women who reside in Harris County, Texas. (Controls)
• No history of prior malignancy with the exception of non-melanoma skin cancer. (Controls)
• Intact uterus. (Controls)
• Patients must sign an informed consent for the study. (Controls)
• Women must speak and understand English or Spanish. (Controls)

You may not qualify if…

• Women who reside outside of Harris County, Texas. (Cases)
• Patients unwilling or unable to provide informed consent. (Cases)
• Metastatic cancer to the endometrium from a different primary. (Cases)
• Women who do not speak and understand English or Spanish. (Cases)
• Women who reside outside of Harris County, Texas. (Controls)
• Previous hysterectomy. (Controls)
• History of prior malignancy with the exception of non-melanoma skin cancer. (Controls)
• Patients unwilling or unable to provide informed consent. (Controls)
• Women who do not speak and understand English or Spanish. (Controls)

Where it is running

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

Full record on ClinicalTrials.gov

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