Early Detection of Barrett's Esophagus

NCT00081354 | Completed

• 2 other identifiers: 04015504-C-0155
• Study Type: observational
• Target: 737
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett's Esophagus

Keywords

Biopsy Tissue; Barrett Esophagus; Gastroesophageal Reflux Disease; GERD; Dysphagia; Swallowing Difficulty

Outcome Measures

Primary Outcomes (1)

• Case Control

  End of Study

Study Arms (2)

Barrett's esophagus

Barrett's esophagus

Controls negative for Barrett's esophagus

Controls negative for Barrett's esophagus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

National Naval Medical Center (NNMC) in Bethesda

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (3)

• Gerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7. doi: 10.1053/gast.2002.34748.

  PMID: 12145799 BACKGROUND

• di Pietro M, Lao-Sirieix P, Boyle S, Cassidy A, Castillo D, Saadi A, Eskeland R, Fitzgerald RC. Evidence for a functional role of epigenetically regulated midcluster HOXB genes in the development of Barrett esophagus. Proc Natl Acad Sci U S A. 2012 Jun 5;109(23):9077-82. doi: 10.1073/pnas.1116933109. Epub 2012 May 17.

  PMID: 22603795 BACKGROUND

• Yasui Y, Pepe M, Thompson ML, Adam BL, Wright GL Jr, Qu Y, Potter JD, Winget M, Thornquist M, Feng Z. A data-analytic strategy for protein biomarker discovery: profiling of high-dimensional proteomic data for cancer detection. Biostatistics. 2003 Jul;4(3):449-63. doi: 10.1093/biostatistics/4.3.449.

  PMID: 12925511 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux; Deglutition Disorders

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Michael B Cook, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2004
• First Posted: April 9, 2004
• Study Start: April 6, 2004
• Primary Completion: January 1, 2013
• Study Completion: May 21, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

US (1)