Early Detection of Barrett's Esophagus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00081354
First received: April 9, 2004
Last updated: April 10, 2014
Last verified: March 2014
  Purpose

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.


Condition
Barrett Esophagus
Esophageal Diseases

Study Type: Observational
Official Title: Barrett's Esophagus Early Detection Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: April 2004
Detailed Description:

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 fold (1), 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 Barretts Esophagus Registry (currently with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda beginning in 1992 as well as 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 analysis 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, we will: (1) assess predictability of BE status from serum proteomic patters; (2) characterize esophageal biopsies and brush samples for selected DNA alterations, RNA expression, and proteomic profiles; (3) genotype patients for selected polymorphisms potentially associated with BE; (4) compare blood and tissue biomarkers in non-BE patients with and without GERD; (5) explore the association of biomarkers with progression from BE to dysplasia or EAC; and (6) assess proteomic pattern stability over time in BE patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081354

Locations
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Investigators
Principal Investigator: Philip R Taylor, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00081354     History of Changes
Obsolete Identifiers: NCT00899106
Other Study ID Numbers: 040155, 04-C-0155
Study First Received: April 9, 2004
Last Updated: April 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Esophageal Adenocarcinoma
Dysplasia
Surveillance
Proteomics
SNP's
Barrett Esophagus
Gastroesophageal Reflux Disease
GERD
Dysphagia
Swallowing Difficulty

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Diseases
Digestive System Abnormalities
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014