The Johns Hopkins Medical Institution is the lead center in a multi-center National Cancer Institute sponsored chemoprevention trial in patients with Barrett’s-associated dysplasia. Patients who have either low or high grade dysplasia will be eligible to be randomized to take either a selective cyclooxygenase-2 (COX-2) inhibitor, celecoxib or placebo. Celecoxib or placebo will be taken twice a day. Celecoxib is currently available by prescription as an anti-inflammatory and analgesic drug. Subjects must be 18 years or older and be willing to abstain from NSAIDs (baby aspirin is permitted).

Prior to trial entry, eligibility testing may include:

• bloodwork,
• upper endoscopy, and
• a medical evaluation by the study physician

The duration of the study is a minimum of 12 months. Patients will undergo regular surveillance endoscopy with biopsies every 3 or 6 months depending on the grade of dysplasia. Extra biopsies for novel biomarker studies will be obtained at these scheduled visits. Patients in the study will receive full informed consent prior to study entry. The total number of patients in the study will be 200.

This study is very exciting because it will yield information about the natural history of dysplasia and provide other options for treatment of dysplasia. There are four other centers in the United States who are participating in this study:

For further information, please contact the study coordinators listed below:   Johns Hopkins Hospital Baltimore, MD Christine Smith, R.N. | clsmith@jhmi.edu Laurie McClelland, R.N. | lam@jhmi.edu Phone: 410-955-3822 Fax: 410-955-3831 Columbia Presbyterian Medical Center New York, NY Kevin Bukowski, R.N. | kb416@columbia.edu Phone: 212-305-3224 Fax: 212-3305-9913 Hines Veterans Administration Hospital Hines, IL Theresa Simon, R.N. | theresa.simon@med.va.gov Phone: 708-202-8387, ext. 23117 Fax: 708-865-2048 www.research.hines.med.va.gov www.vagreatlakes.org University of California Los Angeles Center for the Health Sciences Los Angeles, CA Sheri Wiggett, R.N. | swiggett@ucla.edu Phone: 310-206-8483 Fax: 310-267-1861 Portland Veterans Administration Medical Center Portland, OR Shane Fanning, B.S. | fannings@ohsu.edu Phone: 503-721-1017 Fax: 503-721-7931