NCT00513331

Brief Summary

This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be performed in hopes of identifying biomarkers associated with the progression of BE to esophageal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

6.4 years

First QC Date

August 6, 2007

Last Update Submit

December 31, 2013

Conditions

Barrett's EsophagusGERD

Keywords

Barrett's EsophagusGERDCarcinoma

Outcome Measures

Primary Outcomes (1)

  • To standardize physician recommendations and provide cutting edge technology to patients with BE and GERD, and establish a Valley Hospital Center for Barrett's Esophagus and GERD

    Until study complete

Secondary Outcomes (3)

  • To collect and store patient data regarding their Barrett's esophagus

    Througout Study

  • To collect tissue specimens (biopsy and surgical specimens) for use in proteomic analysis to investigate the dysplasia/carcinoma sequence at the protein expression level.

    throughout Study

  • To assess clinical outcomes of patients enrolled in The Valley Hospital Center for Barrett's Esophagus and GERD, and modify algorithms as appropriate.

    Annually

Study Arms (3)

Algorithm #1

Patients without visable lesions

Procedure: Endoscopy

Algorithm #2

Patients with a visable lesion that is less than 1cm

Procedure: EndoscopyProcedure: Radiofrequency ablation protocolProcedure: Endoscopic mucosal resection protocol

Algorithm #3

Patients with a visable lesion greater than 1cm

Procedure: EndoscopyProcedure: Radiofrequency ablation protocolProcedure: Endoscopic mucosal resection protocol

Interventions

EndoscopyPROCEDURE

Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.

Algorithm #1Algorithm #2Algorithm #3
Radiofrequency ablation protocolPROCEDURE

Ablation using the HALO 360 system according to protocol established by BARRX, Inc.

Algorithm #2Algorithm #3
Endoscopic mucosal resection protocolPROCEDURE

Excision of lesion using DUETTE, marketed by Wilson-Cook

Algorithm #2Algorithm #3

Eligibility Criteria

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

Referred Patients with underlying disease of BE or GERD

You may qualify if:

  • Male or female, age 18 to 85.
  • Patient must have Barrett's Esophagus. Patients may be enrolled based on previous endoscopy reports and/or pathology reports. It is not necessary that each patient have endoscopy for the sole purpose of enrollment.
  • Must agree to allow their clinical information to be collected, stored, analyzed and reported.
  • Must allow portions of their biopsy/surgical specimens to be collected, stored, analyzed and reported.
  • Must agree to fill out patient questionnaires in conjunction with the research study assistant assigned to this protocol (either in person or via telephone contact) at designated timepoints.

You may not qualify if:

  • Intestinal metaplasia of the cardia, without an esophageal columnar lining.
  • Unable to provide informed consent.
  • Unable or unwilling to undergo endoscopic procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Health System - The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood for future analysis

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal RefluxCarcinoma

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition DisordersNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Robert J. Korst, MD

    Valley Health Systems/ The Valley Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

US(1)