Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Missy Tuck, University of Michigan
ClinicalTrials.gov Identifier:
NCT00844077
First received: February 12, 2009
Last updated: December 5, 2011
Last verified: December 2011

February 12, 2009
December 5, 2011
October 2007
April 2011   (final data collection date for primary outcome measure)
Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma. [ Time Frame: 5-8 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00844077 on ClinicalTrials.gov Archive Site
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Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

Barrett's Esophagus
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Barrett's metaplasia
Barrett's intestinal metaplasia, confirmed via pathology, undergoing standard of care endoscopic screening.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
Not Provided
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00844077
GLNE 008, 5U01CA086400-08
Yes
Missy Tuck, University of Michigan
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)
Principal Investigator: Dean E Brenner, MD University of Michigan
University of Michigan
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP