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Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma (FBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00288119
Recruitment Status : Recruiting
First Posted : February 7, 2006
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
Case Western Reserve University
Washington University School of Medicine
Fred Hutchinson Cancer Research Center
University of Washington
Mercy Medical Center
Johns Hopkins University
Mayo Clinic
University of North Carolina, Chapel Hill
The Cleveland Clinic
University of Pennsylvania
Columbia University
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Dr Amitabh Chak, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

The overall objectives of this BETRNet Research Center (RC) are:

  1. to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA)
  2. to increase the biological understanding of key observations made by our clinical researchers;
  3. to translate knowledge derived from genetic, epigenetic, and transcriptome research to solving clinical dilemmas in detection, prognosis, prevention, and therapy of BE in order to prevent EAC and improve the outcomes of EAC;
  4. to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC;
  5. to evaluate research and transdisciplinary programs and to continuously improve research, productivity and enhance translational implementation. These objectives build and synergize on existing multi-institutional collaborative networks and the considerable clinical, basic science, and translational expertise available at our institutions, focusing on improving the outcomes of patients with BE and EAC. The overarching organization framework for this RC proposal is 1) to focus laboratory research on understanding the genetic susceptibility, genomic and epigenetic changes that influence the development of BE and EAC; and 2) to then translate laboratorydiscoveries into clinical applications for effective detection, molecular risk stratification, and prevention of progression from BE to EAC.

Condition or disease Intervention/treatment
Barrett's Esophagus Esophageal Neoplasm Device: Balloon Capsule Device Procedure: Endoscopy

Detailed Description:

This research will eventually lead to the identification of inherited genetic changes that cause Barrett's esophagus and esophageal cancer. It will help the investigators develop better methods for preventing or identifying esophageal cancer at an early curable stage.

The capsule can be swallowed with a few sips water. Once the capsule is advanced to 45-50 cm from the incisors and reaches the stomach the balloon is inflated to a size of 16 mm with 5.5 cc air. It is withdrawn until a tug is felt to locate the gastroesophageal junction (GEJ). The inflated balloon is then pulled back 3 to 5 cm to sample the distal esophagus, then completely deflated to cause inversion of the biospecimen into its protective capsule, and then withdrawn. The balloon is re-inflated outside the patient and the obtained sample is clipped with scissors into a vial and frozen. The collected biospecimen will be stored frozen for later DNA extraction and assay. The vials will be labeled with a coded sample number. In a pilot study of 120 subjects this capsule esophageal sampling was performed with no adverse events reported. Similar esophageal sampling devices have been reported on over 1600 patients with no adverse events.

All patients will also undergo standard EGD. Patients with BE or EAC will have standard of care surveillance and diagnostic biopsies. All cases and controls will have research esophageal brushings from the BE/EAC and distal esophagus/gastric cardia, respectively. Cases and controls will also obtain research brushings from the proximal normal squamous esophagus. Research mucosal biopsies will also be obtained from the BE and EAC epithelium as well as normal stomach and duodenum in cases and from the gastric cardia and the distal squamous esophagus as well as normal stomach and duodenum in controls. Biopsies from BE and EAC will be directed by using high definition narrow band imaging. Biospecimens, brushings and biopsies, will be snap frozen at bedside and stored for future research assays. Although we do not anticipate any problems with our non-endoscopic balloon screening, these archived pathology samples and snap frozen samples will be available for assay in case we fail to detect our markers in patients with BE diagnosed at EGD or experience a high false positive rate. Subjects who undergo non-endoscopic sampling of the distal esophagus will be asked questions that rate their discomfort on a Likert scale and also asked questions comparing the non-endoscopic sampling study with an EGD.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genetic and Environmental Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Actual Study Start Date : October 1, 2005
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD
Device: Balloon Capsule Device
The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection.
Other Name: Esophageal Sampling Device BESD-001

Procedure: Endoscopy
An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
Other Name: EGD

EGD Screening
Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening
Device: Balloon Capsule Device
The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection.
Other Name: Esophageal Sampling Device BESD-001

Procedure: Endoscopy
An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
Other Name: EGD

Colon Screening
Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening
Device: Balloon Capsule Device
The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection.
Other Name: Esophageal Sampling Device BESD-001

Procedure: Endoscopy
An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
Other Name: EGD

Controls
Patients scheduled for EGD who do not meet criteria for screening
Device: Balloon Capsule Device
The Esophageal Sampling Device BESD-001 is a non-endoscopic balloon capsule catheter for obtaining an esophageal mucosal sample. At the distal end of the catheter there is a silicone capsule textured balloon assembly. The textured balloon is initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample. The balloon has a textured surface, which enhances the collection of the esophageal sample. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection.
Other Name: Esophageal Sampling Device BESD-001

Procedure: Endoscopy
An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube.
Other Name: EGD




Primary Outcome Measures :
  1. Assay of DNA and RNA markers [ Time Frame: 1 week ]
    The Balloon tip is collected and sent to the University Hospitals Translation Laboratory to test for DNA extraction


Secondary Outcome Measures :
  1. Score of tolerability and acceptability [ Time Frame: 1 minute after procedure ]
    6 item scale rating scale using scale of 1-10 where 1 is no worries to 10 being severe to rate Tolerability; and a 3 item scale rating the acceptability of Balloon Capsule Device using strongly agree to strongly disagree rating


Biospecimen Retention:   Samples With DNA

Blood Samples from + families with 3 or members diagnosed with BE or ECA will be sent to our NIH approved Biorepository and this repository is designed to help all researchers performing studies on the genetic basis of diseases.

Biospecimens, brushings and biopsies, will be obtained via snap frozen at bedside and stored for future research assays at Case Western Reserve Biorepository.

Balloon Capsule Device Tips are sent to the University Hospitals Transnational Laboratory in Cleveland. The tips are processed for process of assay of DNA and RNA.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with Barrett's esophagus or adenocarcenoma of the esophagus whose medical care is at the participating institutions, are referred from outside institutions, or who contact the participating institutions.
Criteria

Eligible cases will be defined as those patients and their family members who meet the following criteria:

  • Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of the esophagus.
  • Male or female age 18 or older at time of enrollment or male or female less than 18 years of age at time of enrollment with parental consent.
  • Ability to give informed consent, if patient is age 18 or older.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288119


Contacts
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Contact: Amitabh Chak, MD 216-844-5385 axc22@po.cwru.edu
Contact: Wendy Brock, RN 216-844-3853 wendy.brock@UHhospitals.org

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Marcia Canto, M.D.    410-614-5388      
Contact: Hilary Cosby, RN    (410) 502-2893    Hcosby1@jhmi.edu   
Principal Investigator: Marcia I Canto, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ganapathy A Prasad, M.D.    507-255-6930    Prasad.Ganapathy@Mayo.edu   
Contact: Michele Johnson    (507) 293-5307    johnson.michele@Mayo.edu   
Principal Investigator: Ganapathy A Prasad, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jean Wang, MD    314-362-5952    jwang@DOM.wustl.edu   
Contact: Thomas Hollander    314-747-1973    tholland@DOM.wustl.edu   
Principal Investigator: Jean Wang, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Julian Abrams, MD    212-342-0476    ja660@mail.cumc.columbia.edu   
Contact: Adriana Rodriquez    212-304-5606      
Principal Investigator: Julian Abrams, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Nicholas J Shaheen, M.D.    919-966-2513    nshaheen@med.unc.edu   
Contact: Catherine Bracken-Barnes    (919) 843-9616    catherine_bracken@med.unc.edu   
Principal Investigator: Nicholas J Shaheen, M.D.         
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106-8066
Contact: Amitabh Chak, MD    216-844-5386    axc22@po.cwru.edu   
Contact: Wendy Brock, RN    216-844-3853    wendy.brock@UHhospitals.org   
Principal Investigator: Amitabh Chak, MD         
Sub-Investigator: John Dumot, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Prashanthi Thota, MD    216-444-0780    THOTAP@ccf.org   
Contact: Hunter Block-Beach    (216) 442-5382    BLOCKH@ccf.org   
Principal Investigator: Prashanthi Thota, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gary W Falk, MD, MS    215-615-6588    Gary.Falk@uphs.upenn.edu   
Contact: Maureen Demarshall, RN    215-349-8546    demarchm@mail.upenn.edu   
Principal Investigator: Gary W. Falk, MD, MS         
United States, Washington
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Andrew Kaz, MD         
Contact: Julie LaGuire    206-277-6662    julie.laguire@VA.gov   
Fred Hutchinson Cancer Research Center, UWMC Recruiting
Seattle, Washington, United States, 98109
Contact: William Grady, MD    206-667-1107    wgrady@fhcrc.org   
Contact: Wynn Burke       WBurke@medicine.washington.edu   
Principal Investigator: William Grady, MD         
Principal Investigator: Kaz Andrew, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Case Western Reserve University
Washington University School of Medicine
Fred Hutchinson Cancer Research Center
University of Washington
Mercy Medical Center
Johns Hopkins University
Mayo Clinic
University of North Carolina, Chapel Hill
The Cleveland Clinic
University of Pennsylvania
Columbia University
VA Puget Sound Health Care System
Investigators
Layout table for investigator information
Principal Investigator: Amitabh Chak, MD University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH
Principal Investigator: Gary W Falk, MD, MS University of Pennsylvania
Principal Investigator: William Grady, MD Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA
Principal Investigator: Nicholas J Shaheen, M.D. University of North Carolina, Chapel Hill
Principal Investigator: Ganapathy Prasad, M.D. Mayo Clinic
Principal Investigator: Marcia Canto, M.D. Johns Hopkins University
Principal Investigator: John Dumont, D.O. University Hospitals Cleveland Medical Center
Principal Investigator: Prashanthi Thota, M.D. The Cleveland Clinic
Principal Investigator: Jean Wang, MD Washington University School of Medicine
Principal Investigator: Julian Abrams, MD Columbia University
Principal Investigator: Andrew Kaz, MD VA Puget Sound Health Care System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Amitabh Chak, Dr. Amitabh Chak, M.D., Prinicipal Investigator Dr. Gary Falk, M.D. , MS Principal Investigator, Familial Barrett's Esophagus Consortium., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00288119     History of Changes
Obsolete Identifiers: NCT00058877
Other Study ID Numbers: R01DK070863 ( U.S. NIH Grant/Contract )
NIH IK24DK02800
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr Amitabh Chak, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Barrett's Esophagus

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms