Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma (FBE)
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| ClinicalTrials.gov Identifier: NCT00288119 |
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Recruitment Status :
Recruiting
First Posted : February 7, 2006
Last Update Posted : July 15, 2022
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Barrett's Esophagus Esophageal Neoplasm | Device: Balloon Capsule Device Procedure: Endoscopy |
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 It is withdrawn until a tug is felt to locate the gastroesophageal junction (GEJ).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.
| 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 : | July 31, 2023 |
| Estimated Study Completion Date : | July 31, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cases
Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD
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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 |
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EGD Screening
Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening
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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 |
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Colon Screening
Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening
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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 |
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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 |
- Assay of DNA and RNA markers [ Time Frame: 1 week ]The Balloon tip is collected and sent to the PacificDx Laboratory in Irvine California to test for DNA extraction
- 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.
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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 |
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.
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
| Contact: Amitabh Chak, MD | 216-844-5385 | axc22@po.cwru.edu | |
| Contact: Wendy Brock, RN | 216-844-3853 | wendy.brock@UHhospitals.org |
| 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: Ramona Lansing 507-538-4974 lansing.ramona@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: Alondra Santiago (919) 843-8571 alondra_santiago@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: Vidhi Patel, MD (216) 444-0780 VPatel@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 | |
| 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):
| 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 |
| 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 15, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
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Barrett's Esophagus |
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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 |