Barrett's EsophagusFBENCT00288119
Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
An observational study of Barrett's Esophagus and Esophageal Neoplasm, run by Case Western Reserve University at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus, Esophageal Neoplasm
- What is being tested?
- Balloon Capsule Device and Endoscopy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Oct 2005to 31 Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Marcia Canto, M.D., (410) 614-5388
Hilary Cosby, RN, (410) 502-2893, Hcosby1@jhmi.edu
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Nicholas J Shaheen, M.D., 919-966-2513, nshaheen@med.unc.edu
Alondra Santiago, (919) 843-8571, alondra_santiago@med.unc.edu
- Recruiting
University Hospitals of Cleveland
Cleveland, Ohio, 44106-8066
Amitabh Chak, MD, 216-844-5386, axc22@po.cwru.edu
Wendy Brock, RN, 216-844-3853, wendy.brock@UHhospitals.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Prashanthi Thota, MD, 216-444-0780, THOTAP@ccf.org
Vidhi Patel, MD, (216) 444-0780, VPatel@ccf.org
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Julian Abrams, MD, 212-342-0476, ja660@mail.cumc.columbia.edu
Adriana Rodriquez, 212-304-5606
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Gary W Falk, MD, MS, 215-615-6588, Gary.Falk@uphs.upenn.edu
Maureen Demarshall, RN, 215-349-8546, demarchm@mail.upenn.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Ganapathy A Prasad, M.D., (507) 255-6930, Prasad.Ganapathy@Mayo.edu
Ramona Lansing, 507-538-4974, lansing.ramona@mayo.edu
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Andrew Kaz, MD
Julie LaGuire, 206-277-6662, julie.laguire@VA.gov
- Recruiting
Fred Hutchinson Cancer Research Center, UWMC
Seattle, Washington, 98109
William Grady, MD, 206-667-1107, wgrady@fhcrc.org
Wynn Burke, WBurke@medicine.washington.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Jean Wang, MD, 314-362-5952, jwang@DOM.wustl.edu
Thomas Hollander, 314-747-1973, tholland@DOM.wustl.edu
About this study
Official title: Genetic and Environmental Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
The overall objectives of this BETRNet Research Center (RC) are:
- to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA)
- to increase the biological understanding of key observations made by our clinical researchers;
- 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;
- to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC;
- 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.
Read the 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.
- Conditions
- Barrett's Esophagus, Esophageal Neoplasm
- Being tested
- Balloon Capsule Device, Endoscopy
- Keywords
- Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Capsule DeviceDevice
Also called Esophageal Sampling Device BESD-001
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.
EndoscopyProcedure or surgery
Also called EGD
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD Receives: Device: Balloon Capsule Device; Procedure: Endoscopy | |
| EGD Screening | Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening Receives: Device: Balloon Capsule Device; Procedure: Endoscopy | |
| Colon Screening | Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening Receives: Device: Balloon Capsule Device; Procedure: Endoscopy | |
| Controls | Patients scheduled for EGD who do not meet criteria for screening Receives: Device: Balloon Capsule Device; Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assay of DNA and RNA markers
The Balloon tip is collected and sent to the PacificDx Laboratory in Irvine California to test for DNA extraction
Measured: 1 week
Secondary outcomes (1)
Score of tolerability and acceptability
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
Measured: 1 minute after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study start1 Oct 2005
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, Washington University School of Medicine, Fred Hutchinson Cancer 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
- Responsible party
- Sponsor
- Investigators
- Amitabh Chak, MD, Principal investigator, University Hospitals Cleveland Medical Center, CWRU, Cleveland, OHGary W Falk, MD, MS, Principal investigator, University of PennsylvaniaWilliam Grady, MD, Principal investigator, Fred Hutchinson Cancer Research Center, UWMC, Seattle, WANicholas J Shaheen, M.D., Principal investigator, University of North Carolina, Chapel HillGanapathy Prasad, M.D., Principal investigator, Mayo ClinicMarcia Canto, M.D., Principal investigator, Johns Hopkins UniversityJohn Dumont, D.O., Principal investigator, University Hospitals Cleveland Medical CenterPrashanthi Thota, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288119
- Sponsor's protocol ID
- R01DK070863
- Other IDs
- NIH IK24DK02800
- Acronym
- FBE
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2006
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Douville C, Moinova HR, Thota PN, Shaheen NJ, Iyer PG, Canto MI, Wang JS, Dumot JA, Faulx A, Kinzler KW, Papadopoulos N, Vogelstein B, Markowitz SD, Bettegowda C, Willis JE, Chak A. Massively Parallel Sequencing of Esophageal Brushings Enables an Aneuploidy-Based Classification of Patients With Barrett's Esophagus. Gastroenterology. 2021 May;160(6):2043-2054.e2. doi: 10.1053/j.gastro.2021.01.209. Epub 2021 Jan 22.
PubMed 33493502Moinova HR, Verma S, Dumot J, Faulx A, Iyer PG, Canto MI, Wang JS, Shaheen NJ, Thota PN, Aklog L, Willis JE, Markowitz SD, Chak A. Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma. Am J Gastroenterol. 2024 Nov 1;119(11):2206-2214. doi: 10.14309/ajg.0000000000002850. Epub 2024 Apr 30.
PubMed 38686933Chak A, Chen Y, Vengoechea J, Canto MI, Elston R, Falk GW, Grady WM, Guda K, Kinnard M, Markowitz S, Mittal S, Prasad G, Shaheen N, Willis JE, Barnholtz-Sloan JS. Variation in age at cancer diagnosis in familial versus nonfamilial Barrett's esophagus. Cancer Epidemiol Biomarkers Prev. 2012 Feb;21(2):376-83. doi: 10.1158/1055-9965.EPI-11-0927. Epub 2011 Dec 16.
PubMed 22178570