NCT02075905

Brief Summary

Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab for analysis of a validated biomarker panel. Subjects will be stratified to either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia will receive surveillance endoscopy in 1 year per routine care. All subjects will be administered a questionnaire seeking information about hypothetical willingness to be randomized to treatment or surveillance.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
3 countries

4 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

First Submitted

Initial submission to the registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

February 27, 2014

Last Update Submit

December 19, 2016

Conditions

Barrett's EsophagusEsophageal AdenocarcinomaIntestinal MetaplasiaDysplasia

Keywords

Barrett's EsophagusEsophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Risk Stratification

    This is a pilot study the main objective of which is to determine feasibility and preparation for a larger scale study. Baseline tissue samples will be used to stratify subjects as either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel risk stratification will be compared to data collected 1 year post enrollment regarding current pathology and ablation treatments received since enrollment.

    Baseline

Study Arms (2)

Barrett's Esophagus-Low Grade Dysplasia

Subjects enrolled who have Barrett's Esophagus with low grade dysplasia. No research intervention is administered.

Barrett's Esophagus-no dysplasia

Subjects enrolled with Barrett's Esophagus and no dysplasia. No research intervention is administered.

Eligibility Criteria

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

Subjects with Barrett's Esophagus, coming into clinics for routine care surveillance upper endoscopy procedures.

You may qualify if:

  • Able to read, comprehend, and complete the consent form.
  • Aged 18 to 80.
  • Diagnosed with at least 3 centimeters (\>3cm) of Barrett's Esophagus (BE) AND no dysplasia or low grade dysplasia per review by pathologist.

You may not qualify if:

  • Pregnant women.
  • Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after EGD).
  • Known bleeding disorder.
  • Status post partial or complete esophageal resection.
  • Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
  • Prior ablative therapy of the esophagus including prior radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, and other ablation therapies. Prior endoscopic mucosal resection (EMR) is acceptable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Academic Medical Center

Amsterdam, 1100 DD, Netherlands

Location

University of Cambridge

Cambridge, CB2 0XZ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin embedded esophageal biopsies

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Nicholas J Shaheen, MD, MPH

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Epidemiology; Chief, Division of Gastroenterology & Hepatology

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 20, 2016

Record last verified: 2016-12

Locations

NL(1)US(2)GB(1)