Protocol Number: 04-C-0155

Title:

Barrett's Esophagus Early Detection Study

Number:

04-C-0155

Summary:

This study will identify markers in the blood that can be used as a screening test for Barrett's esophagus (BE), a condition in which the cells lining the esophagus (muscular food tube leading from the throat to the stomach) are replaced by a different type of cell more like those lining the stomach. Patients with BE are at increased risk of developing esophageal cancer. The lack of early symptoms and the rapid spread of disease in esophageal cancer often leads to late diagnosis and poor prognosis. Early detection and intervention may reduce mortality from this disease. This study will compare blood and tissue samples from patients diagnosed with BE to those from a control group of patients without BE to look for differences that may be used to indicate the presence of BE.

People 18 years of age with the following conditions may be eligible for this study:

- Stomach or esophageal reflux, or

- Barrett's esophagus, or

- Dysphagia (difficulty swallowing), or

- Anemia, or

- Gastrointestinal bleeding, or

- Other conditions requiring endoscopic evaluation

Candidates for the study are recruited from patients listed in the Barrett's Esophagus Registry of the National Naval Medical Center (NNMC) in Bethesda, Maryland, and non-BE patients undergoing endoscopy at NNMC for other conditions.

Participants undergo the following tests and procedures:

- Questionnaires about their medical and surgical history, including smoking and alcohol use, and family history of reflux, Barrett's esophagus, and cancer.

- Blood draws for routine and research tests, including gene and protein analyses

- Upper endoscopy with biopsies to examine the esophagus and stomach and to collect tissue specimens for analysis. For this diagnostic test, an anesthetic such as lidocaine is sprayed into the patient's mouth and throat to suppress the gag reflex during insertion of the endoscope, a flexible plastic tube with a light at the end. Through this tube, the physician inspects the lining of the esophagus, stomach, and duodenum, and collects small tissue samples for laboratory study.

Patients are followed at NNMC at regular intervals for a physical examination and blood tests. Additional biopsies may be obtained from BE patients with abnormal cells.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Patient population is being recruited from a NAVY protocol.

Disease Category:

PROTICD

Keywords:

Esophageal Adenocarcinoma

Dysplasia

Surveillance

Proteomics

SNP's

Recruitment Keywords:

Barrett Esophagus

Gastroesophageal Reflux Disease

GERD

Dysphagia

Swallowing Difficulty

Conditions:

Barrett Esophagus

Esophageal Diseases

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Morales TG, Sampliner RE. Barrett's esophagus: update on screening, surveillance, and treatment. Arch Intern Med. 1999 Jul 12;159(13):1411-6. Review.

PMID: 10399892

Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the

United States. Cancer. 1998 Nov 15;83(10):2049-53.

PMID: 9827707

Reid BJ, Levine DS, Longton G, Blount PL, Rabinovitch PS.

Predictors of progression to cancer in Barrett's esophagus: baseline histology and flow cytometry identify low- and high-risk patient subsets. Am J Gastroenterol. 2000 Jul;95(7):1669-76.

PMID: 10925966

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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