Status:
COMPLETED
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Early Detection Research Network
M.D. Anderson Cancer Center
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18-80 years
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). Pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00844077
Start Date
October 1 2007
Last Update
December 7 2011
Active Locations (6)
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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