Familial Barrett's Esophagus Study

IRB Number : 1037-98

Trial Status: Open for Enrollment

Phase: I

Why is this study being done?

A group of doctors and scientists at the Mayo Clinic in Rochester, Minnesota, along with doctors from many other medical centers throughout the US, are working together to advance our understanding of Barrett's esophagus and esophagus cancer. The main aim of the present study is to collect blood for future testing. Once all the samples have been collected, tests to identify genes that may be involved in the development of Barrett's will be performed. A future goal is to learn if there is a genetic difference between those people who have Barrett's and develop cancer, and those who do not.

Who is Eligible to Participate in the Study?

Families that have several people affected with Barrett's esophagus, whether or not they have esophagus cancer, will give us the most information about genes related to this disease. For those people who were initially diagnosed with esophagus cancer, there must be evidence of Barrett's esophagus in the background of the tumor to participate as an index case. Your doctor, or the researchers at Mayo, will be able to inform you if you meet criteria to participate in this study. Women and men, who may or may not have had Barrett's esophagus or cancer themselves, and who are relatives of individuals who have had Barrett's esophagus or esophagus cancer will be asked to participate in this study.

What is Involved With this Study?

As a study participant you will be asked to:

  1. Answer questions regarding your health history and about risk factors for Barrett's esophagus and esophagus cancer.
  2. Donate approximately 50 cc (5-6 tablespoons) of blood.
  3. Authorize release of your medical records and/or tissue sample from any previous endoscopy or esophagus surgery from your physician to Mayo Clinic investigators participating in this study.

How long will the Study run?

There are no monetary costs to you as part of your participation in the study. Some of your time, however, will be spent completing a questionnaire and having your blood drawn (only once). You may send your bill for blood collection to the Mayo Clinic so that you will not be charged. If you choose not to participate, you will not jeopardize present or future medical care and treatment by your doctor or doctors at the Mayo Clinic. Barrett's esophagus is a complication of gastroesophageal reflux disease (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 (intestinal metaplasia with goblet cells). Patients with Barrett's have a 30-125 times increased 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 4%-10% per year in recent decades. The cause of the increase is unknown. Similarly, the role of genetic factors in Barrett's esophagus and esophagus cancer is not known.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Debra Geno at 507-538-0367.

What is/are the Locations of this Clinical Trial?

Rochester, MN