IRB Number:

85-04

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to:

• Collect tissue, urine and blood samples from patients who have endometrial cancer.


• Collect information from patients (for example: age, race, level of education, health history, family health history, and treatments for cancer).


• Learn more about, treat and prevent endometrial cancer.


• Create a tissue storage bank for samples sent to the studys sponsor, the Gynecologic Oncology Group (GOG).

Who is Eligible to Participate in the Study?

You have been asked to be in this study because you have endometrial cancer (cancer of the lining of the uterus or womb). The standard treatment for this cancer is a hysterectomy (removal of the uterus) along with removal of both fallopian tubes and ovaries. Lymph nodes, which are small "kernel" shaped glands in your pelvis and near the main blood vessel in your abdomen (lower aorta), will also be taken out because endometrial cancer may spread to these areas. This is called surgical staging. If cancer is found in places other than your uterus, fallopian tubes or ovaries, your surgeon may decide to remove it from these places as well. The removal of the tissue will help your doctors decide if more treatment other than surgery should be done. The treatment will be explained to you by your doctor(s) and you will be asked to sign a separate consent form for this.

What is Involved With this Study?

Some of the tissue that is removed during your surgery, but is not needed to diagnose your cancer, will be saved. In addition, a small amount of your urine (about 3 tablespoons) will be collected from a catheter bag during your surgery. Blood (about 3 tablespoons taken from a needle in a vein in your arm) will be collected before your surgery and again at two follow-up visits (about 6 weeks after your surgery and again 3 years after your surgery).

After your surgery, your doctor will talk with you about whether you need any further treatment. You will be seen for follow-up examinations at least every 3 months for the first year after your surgery, every 6 months for the next 2 years and then once a year for the next 7 years. This means that you will be seen for up to 10 years after you have your surgery.

If your cancer returns or gets worse, you will be asked to give another blood sample and have a biopsy of your tumor, if possible, at that time.

How long will the Study run?

You will be in the study for about 10 years.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 03/31/2008