Protocol Details

Barrett's esophagus Early Detection Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	04-C-0155
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	Yes
Population Exclusion(s)	Children
Special Instructions	Patient population is being recruited from a NAVY protocol.
Keywords	Esophageal Adenocarcinoma; Dysplasia; Surveillance; Proteomics; SNP's
Recruitment Keyword(s)	Barrett esophagus; Gastroesophageal Reflux Disease; GERD; Dysphagia; Swallowing Difficulty
Condition(s)	Barrett esophagus; Esophageal Diseases
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

Background:

The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past two decades and is the most rapidly increasing cancer in the U.S.

Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125, and is considered a precursor lesion for EAC.

Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous diagnosis of BE or have been part of a surveillance program, so alternative screening methods are needed.

Objectives:

The primary goal of this project is to identify a practical blood-based biomarker(s) that can be used as a screening test to determine who has BE and who does not.

Secondary goals of the project are to characterize germ-line and tissue biomarkers associated with BE, and to compare biomarkers in non-BE patients with and without GERD.

Tertiary goals are to explore associations between biomarkers in blood or tissue and progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns over time.

Eligibility:

This study will be conducted among patients in the Barrett's esophagus Registry (currently with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda beginning in 1992, as well as a comparison group of approximately 600 matched non-BE patients endoscoped in the GI clinic at NNMC for other conditions.

Design:

Blood and tissue samples will be collected as well as questionnaire data on risk factors and medications as well as GERD.

Data analyses will be based primarily on laboratory testing of newly collected esophageal biopsies, brush samples, and blood samples, but secondarily will also include use of archival tissue biopsy samples.

Follow up of BE Registry patients will include standard periodic surveillance endoscopies, additional blood samples, and ascertainment of disease status (i.e., progression).

To distinguish BE versus non BE-patients in this case-control study, we will:

assess predictability of BE status from serum proteomic patterns;

characterize esophageal biopsies and brush samples for selected DNA alterations, RNA expression, and proteomic profiles;

genotype patients for selected polymorphisms potentially associated with BE;

compare blood and tissue biomarkers in non-BE patients with and without GERD;

explore the association of biomarkers with progression from BE to dysplasia or EAC;

assess proteomic pattern stability over time in BE patients.

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Eligibility

INCLUSION CRITERIA

Inclusion criteria for EGD in this study include:

Greater than or equal to 18 years of age, and

presence of GERD or GERD-like symptoms, or

presence of BE, or

dysphagia, or

anemia, or

gastrointestinal bleeding, or

presence of other conditions (e.g., dyspepsia) that merit endoscopic evaluation.

EXCLUSION CRITERIA

Exclusion criteria for EGD in this study include:

severe pulmonary or cardiac disease, or

pregnancy, or

refusal, or

inability or refusal to give consent, or

age less than 18 years or participation in NNMC Barrett's esophagus cryotherapy protocol, or

malignancy other than nonmelanoma skin cancer.

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Citations:

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

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.

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.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Philip R. Taylor, M.D. National Cancer Institute (NCI) National Institutes of Health Executive Plaza South Room 7006 6120 Executive Boulevard Rockville, Maryland 20852 (301) 594-2932 ptaylor@mail.nih.gov	Philip R. Taylor, M.D. National Cancer Institute (NCI) National Institutes of Health Executive Plaza South Room 7006 6120 Executive Boulevard Rockville, Maryland 20852 (301) 594-2932 ptaylor@mail.nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937

Clinical Trials Number:

NCT00081354

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