Clincosm LogoSign in Get a demo

Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT00844077
Collaborator
Early Detection Research Network (Other), M.D. Anderson Cancer Center (Other), Unity Health Toronto (Other), Dana-Farber Cancer Institute (Other), Dartmouth-Hitchcock Medical Center (Other), Columbia University (Other), Icahn School of Medicine at Mount Sinai (Other), National Cancer Institute (NCI) (NIH)
255
Enrollment
6
Locations
42.5
Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    255 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma
    Study Start Date :
    Oct 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Barrett's metaplasia

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

    Outcome Measures

    Primary Outcome Measures

    1. Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma. [5-8 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Dana Farber Cancer Institute Boston Massachusetts United States
    2 University of Michigan Ann Arbor Michigan United States 48109
    3 Columbia University New York New York United States
    4 Mt. Sinai School of Medicine New York New York United States
    5 MD Anderson Cancer Center Houston Texas United States
    6 St. Michael's Hospital Toronto Ontario Canada

    Sponsors and Collaborators

    • University of Michigan
    • Early Detection Research Network
    • M.D. Anderson Cancer Center
    • Unity Health Toronto
    • Dana-Farber Cancer Institute
    • Dartmouth-Hitchcock Medical Center
    • Columbia University
    • Icahn School of Medicine at Mount Sinai
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Dean E Brenner, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Missy Tuck, Project manager, Clinical Trials, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT00844077
    Other Study ID Numbers:
    • GLNE 008
    • 5U01CA086400-08
    First Posted:
    Feb 13, 2009
    Last Update Posted:
    Dec 7, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by Missy Tuck, Project manager, Clinical Trials, University of Michigan
    Barrett's Intestinal Metaplasia
    Additional relevant MeSH terms:
    Barrett Esophagus

    Study Results

    No Results Posted as of Dec 7, 2011