Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
NCT ID: NCT00844077
Last Updated: 2011-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Barrett's metaplasia
Barrett's intestinal metaplasia, confirmed via pathology, undergoing standard of care endoscopic screening.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Early Detection Research Network
NETWORK
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
University of Michigan
OTHER
Responsible Party
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Missy Tuck
Project manager, Clinical Trials
Principal Investigators
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Dean E Brenner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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GLNE 008
Identifier Type: -
Identifier Source: org_study_id