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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. completion date
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


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
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