NCT00844077

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). 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

3.5 years

First QC Date

February 12, 2009

Last Update Submit

December 5, 2011

Conditions

Barrett's Esophagus

Keywords

Barrett's Intestinal Metaplasia

Outcome Measures

Primary Outcomes (1)

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

    5-8 years

Study Arms (1)

Barrett's metaplasia

Barrett's intestinal metaplasia, confirmed via pathology, undergoing standard of care endoscopic screening.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Columbia University

New York, New York, United States

Location

Mt. Sinai School of Medicine

New York, New York, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dean E Brenner, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project manager, Clinical Trials

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

October 1, 2007

Primary Completion

April 1, 2011

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations

US(5)CA(1)