Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
NCT ID: NCT00288119
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2005-10-01
2028-07-31
Brief Summary
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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.
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Detailed Description
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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 It is withdrawn until a tug is felt to locate the gastroesophageal junction (GEJ).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distal esophagus, then completely deflated to cause inversion of the biospecimen into its protective capsule, and then withdrawn.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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cases
Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD
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.
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.
EGD Screening
Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening
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.
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.
Colon Screening
Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening
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.
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.
Controls
Patients scheduled for EGD who do not meet criteria for screening
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Washington University School of Medicine
OTHER
Fred Hutchinson Cancer Center
OTHER
University of Washington
OTHER
Mercy Medical Center
OTHER
Johns Hopkins University
OTHER
Mayo Clinic
OTHER
University of North Carolina, Chapel Hill
OTHER
The Cleveland Clinic
OTHER
University of Pennsylvania
OTHER
Columbia University
OTHER
VA Puget Sound Health Care System
FED
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Amitabh Chak, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH
Gary W Falk, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
William Grady, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA
Nicholas J Shaheen, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Ganapathy Prasad, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Marcia Canto, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
John Dumont, D.O.
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Prashanthi Thota, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Jean Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Julian Abrams, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Andrew Kaz, MD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, UWMC
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Marcia Canto, M.D.
Role: primary
Adriana Rodriquez
Role: backup
Andrew Kaz, MD
Role: primary
References
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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.
Moinova 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.
Chak 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.
Other Identifiers
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NIH IK24DK02800
Identifier Type: -
Identifier Source: secondary_id
NCT00058877
Identifier Type: -
Identifier Source: nct_alias
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