Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

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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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma.

Time frame: 5-8 years

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma

Important dates

Study start: 2007
Primary completion: 2011
First posted: Feb 13, 2009
Registry last updated: Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed