Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

This study has been completed.

First Received on February 12, 2009. Last Updated on December 5, 2011 History of Changes

Sponsor:	University of Michigan
Collaborators:	Early Detection Research Network M.D. Anderson Cancer Center St. Michael's Hospital, Toronto Dana-Farber Cancer Institute Dartmouth-Hitchcock Medical Center Columbia University Mount Sinai School of Medicine National Cancer Institute (NCI)
Information provided by (Responsible Party):	Missy Tuck, University of Michigan
ClinicalTrials.gov Identifier:	NCT00844077

Purpose

Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia without dysplasia to look for predictive factors for transformation to dysplasia or cancer. Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and Normal esophageal mucosa. In addition, the investigators are testing a brushing technique from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's intestinal metaplasia without history of dysplasia to be on this longitudinal study.

Condition
Barrett's Esophagus

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma. [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Plasma,serum, DNA, urine, Barrett's tissue (Fixed and Frozen), Normal Esophagus tissue (Fixed and Frozen)

Enrollment:	255
Study Start Date:	October 2007
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Barrett's metaplasia Barrett's intestinal metaplasia, confirmed via pathology, undergoing standard of care endoscopic screening.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects undergoing clinically-indicated upper endoscopy for surveillance of their pathologically-confirmed Barrett's intestinal metaplasia. Recruitment is from the Endoscopy schedules of the collaborating locations.

Criteria

Inclusion Criteria:

Adults (> 18 years old)
Subjects with pathologically confirmed Barrett's esophagus, including:
Intestinal metaplasia without dysplasia, long and short segments (>1 cm)
Intestinal metaplasia without dysplasia, long and short segments (>1 cm), previously in GLNE 003
Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of indefinite-for-dysplasia) provided there is no history of HGD, or EAC.
Intestinal metaplasia without dysplasia or indefinite-for-dysplasia with a history of LGD provided the last surveillance endoscopy showed IM alone, the LGD history was at least 12 or more months ago and there is no history of HGD or EAC.
Able to physically tolerate removal of 34 ml of blood
Tolerate extra research related biopsies and brushings
Willing to permit extra biopsies at future endoscopic procedures
Ability and willingness to complete questionnaires
Willing to sign informed consent Exclusion Criteria
Subjects with a pathologically confirmed history of Barrett's, HGD or EAC
Subjects with pathologically confirmed history of Barrett's LGD within the last 12 months.
Subjects in whom esophageal biopsy would be contraindicated (eq. varices)
Subjects with serious infections requiring IV antibiotics
Subjects with known HIV or chronic viral hepatitis
Subjects on active chemotherapy or radiation treatment
Subjects who have had an esophagectomy
Subjects with an active malignancy diagnosed or treated within 3 years except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin; Carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844077

Locations

United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada

Sponsors and Collaborators

University of Michigan

Early Detection Research Network

M.D. Anderson Cancer Center

St. Michael's Hospital, Toronto

Dana-Farber Cancer Institute

Dartmouth-Hitchcock Medical Center

Columbia University

Mount Sinai School of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Dean E Brenner, MD

University of Michigan

More Information

No publications provided

Responsible Party:	Missy Tuck, Project manager, Clinical Trials, University of Michigan
ClinicalTrials.gov Identifier:	NCT00844077 History of Changes
Other Study ID Numbers:	GLNE 008, 5U01CA086400-08
Study First Received:	February 12, 2009
Last Updated:	December 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Barrett's Intestinal Metaplasia

Additional relevant MeSH terms:

Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012