Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844077
• Other study ID #: GLNE 008
• Secondary ID: 5U01CA086400-08
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: December 5, 2011
• Start date: October 2007

Study information

• Verified date: December 2011
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
University of Michigan	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), St. Michael's Hospital, Toronto

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma.		5-8 years	No