IRB Number:

495-01

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to advance the understanding of how esophagus cancer and Barrett's Esophagus develop as well as ways to treat these conditions. This will be done by analyzing blood and tissue to identify genes that may be involved in the development of esophagus cancer and Barrett's Esophagus.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 who have esophagus cancer or Barrett's Esophagus.

Esophagus Cancer - there are two major types of esophagus cancer:

Squamous cell cancer usually arises in the
upper part of the esophagus. This type of cancer is most common in older men who use tobacco and alcohol.

Adenocarcinoma commonly arises from Barrett's esophagus in the lower part of the esophagus. Although older men who smoke are at the greatest risk, Gastro Esophageal Reflux Disease (GERD) is an additional risk factor for this type of cancer.

Barrett's Esophagus

Barrett's esophagus is a complication of GERD. In Barrett's esophagus, reflux of gastric contents damage the normal lining of the lower esophagus, which is then replaced by a different type of lining. Patients with Barrett's esophagus have a much greater risk of developing esophagus
cancer compared to the general population. Adenocarcinoma of the esophagus, which usually arises in a Barrett's esophagus, has been increasing in incidence in the United
States by four to ten percent per year in recent decades. The cause of the increase is unknown. Similarly, the role of genetic factors in Barrett's esophagus is not known.

Additional Requirements / Information

What is involved in this research study?

As a study participant you will be asked to:

• Answer questions about heartburn, difficulty swallowing, chest pain, history of previous cancer, tobacco use, beverage consumption and quality of life. These questionaires may be answered at home. Pre-addressed and postage-paid envelopes are available.
  
  
• Donate approximately three and a half tablespoons of blood for genetic testing.
  
  
• Give permission to do research on a small amount of tissue removed during scheduled endoscopy or surgery. To use and study your tissue or blood, we need your informed, written consent.
  
  
• You will be asked to answer one or two questionnaires on an annual basis.

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.
- Patients living outside the United States (International patient inquiries), call 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: 07/30/2009