[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100079306":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":42,"centralContacts":77,"locations":86,"responsibleParty":267,"collaborators":269,"id":286,"slug":287,"hasResults":288,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":294,"sex":295,"minAge":296,"maxAge":10,"enrollmentInfo":297,"targetDuration":10,"studyType":300,"phases":10,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":89,"whyStopped":10,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases",null,"Patients with Barrett's esophagus undergoing surveillance or patients with esophageal adenocarcinoma and esophagogastric junctional adenocarcinoma undergoing EGD",[13,14],"Device: Balloon Capsule Device","Procedure: Endoscopy",{"label":16,"type":10,"description":17,"interventionNames":18},"EGD Screening","Patients scheduled for clinically indicated EGD for GERD who meet ACG criteria for BE screening",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Colon Screening","Patients scheduled for screening colonoscopy who have not had EGD and meet clinically indicated criteria for BE screening",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Controls","Patients scheduled for EGD who do not meet criteria for screening",[13,14],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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initially inverted with vacuum for patient to swallow the capsule but then is inflated with 5.6 cc of air (5 cc syringe withdrawn maximally) to a 16-18 mm diameter in order to contact the lumen of the esophagus to collect a sample.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.",[9,20,24,16],[34],"Esophageal Sampling Device BESD-001",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"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.",[9,20,24,16],[41],"EGD",[43,47,50,53,56,59,62,65,68,71,74],{"name":44,"affiliation":45,"role":46},"Amitabh Chak, MD","University Hospitals Cleveland Medical Center, CWRU, Cleveland, OH","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":49,"role":46},"Gary W Falk, MD, MS","University of Pennsylvania",{"name":51,"affiliation":52,"role":46},"William Grady, MD","Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA",{"name":54,"affiliation":55,"role":46},"Nicholas J Shaheen, M.D.","University of North Carolina, Chapel Hill",{"name":57,"affiliation":58,"role":46},"Ganapathy Prasad, M.D.","Mayo Clinic",{"name":60,"affiliation":61,"role":46},"Marcia Canto, M.D.","Johns Hopkins University",{"name":63,"affiliation":64,"role":46},"John Dumont, D.O.","University Hospitals Cleveland Medical Center",{"name":66,"affiliation":67,"role":46},"Prashanthi Thota, M.D.","The Cleveland Clinic",{"name":69,"affiliation":70,"role":46},"Jean Wang, MD","Washington University School of Medicine",{"name":72,"affiliation":73,"role":46},"Julian Abrams, MD","Columbia University",{"name":75,"affiliation":76,"role":46},"Andrew Kaz, MD","VA Puget Sound Health Care System",[78,82],{"name":44,"role":79,"phone":80,"phoneExt":10,"email":81},"CONTACT","216-844-5385","axc22@po.cwru.edu",{"name":83,"role":79,"phone":84,"phoneExt":10,"email":85},"Wendy Brock, 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Rodriquez","212-304-5606",{"name":72,"role":46,"phone":10,"phoneExt":10,"email":10},{"facility":165,"status":89,"city":166,"state":167,"zip":168,"country":93,"countryCode":94,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":96,"coordinates":170},[171,172],-79.05584,35.9132,{"lat":172,"lon":171},[175,178,182],{"name":54,"role":79,"phone":176,"phoneExt":10,"email":177},"919-966-2513","nshaheen@med.unc.edu",{"name":179,"role":79,"phone":180,"phoneExt":10,"email":181},"Alondra Santiago","(919) 843-8571","alondra_santiago@med.unc.edu",{"name":54,"role":46,"phone":10,"phoneExt":10,"email":10},{"facility":184,"status":89,"city":185,"state":186,"zip":187,"country":93,"countryCode":94,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University Hospitals of Cleveland","Cleveland","Ohio","44106-8066",{"type":96,"coordinates":189},[190,191],-81.69541,41.4995,{"lat":191,"lon":190},[194,196,197,198],{"name":44,"role":79,"phone":195,"phoneExt":10,"email":81},"216-844-5386",{"name":83,"role":79,"phone":84,"phoneExt":10,"email":85},{"name":44,"role":46,"phone":10,"phoneExt":10,"email":10},{"name":199,"role":200,"phone":10,"phoneExt":10,"email":10},"John Dumot, MD","SUB_INVESTIGATOR",{"facility":202,"status":89,"city":185,"state":186,"zip":203,"country":93,"countryCode":94,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"Cleveland Clinic","44195",{"type":96,"coordinates":205},[190,191],{"lat":191,"lon":190},[208,212,216],{"name":209,"role":79,"phone":210,"phoneExt":10,"email":211},"Prashanthi Thota, MD","216-444-0780","THOTAP@ccf.org",{"name":213,"role":79,"phone":214,"phoneExt":10,"email":215},"Vidhi Patel, MD","(216) 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Falk, MD, MS",{"facility":76,"status":89,"city":237,"state":238,"zip":239,"country":93,"countryCode":94,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Seattle","Washington","98108",{"type":96,"coordinates":241},[242,243],-122.33207,47.60621,{"lat":243,"lon":242},[246,247],{"name":75,"role":79,"phone":10,"phoneExt":10,"email":10},{"name":248,"role":79,"phone":249,"phoneExt":10,"email":250},"Julie LaGuire","206-277-6662","julie.laguire@VA.gov",{"facility":252,"status":89,"city":237,"state":238,"zip":253,"country":93,"countryCode":94,"cosmosGeoPoint":254,"geoPoint":256,"contacts":257},"Fred Hutchinson Cancer Research Center, UWMC","98109",{"type":96,"coordinates":255},[242,243],{"lat":243,"lon":242},[258,261,264,265],{"name":51,"role":79,"phone":259,"phoneExt":10,"email":260},"206-667-1107","wgrady@fhcrc.org",{"name":262,"role":79,"phone":10,"phoneExt":10,"email":263},"Wynn Burke","WBurke@medicine.washington.edu",{"name":51,"role":46,"phone":10,"phoneExt":10,"email":10},{"name":266,"role":46,"phone":10,"phoneExt":10,"email":10},"Kaz Andrew, MD",{"type":268,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[270,271,272,274,276,278,279,280,281,282,283,284],{"name":64,"class":6},{"name":70,"class":6},{"name":273,"class":6},"Fred Hutchinson Cancer Center",{"name":275,"class":6},"University of Washington",{"name":277,"class":6},"Mercy Medical Center",{"name":61,"class":6},{"name":58,"class":6},{"name":55,"class":6},{"name":67,"class":6},{"name":49,"class":6},{"name":73,"class":6},{"name":76,"class":285},"FED","100079306","genetic-determinants-of-barretts-esophagus-and-esophageal-adenocarcinoma-100079306",false,"NCT00288119","Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma","Genetic and Environmental Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma","FBE","Eligible cases will be defined as those patients and their family members who meet the following criteria:\n\n* 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.\n* 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.\n* Ability to give informed consent, if patient is age 18 or older.",true,"ALL","18 Years",{"count":298,"type":299},2000,"ESTIMATED","OBSERVATIONAL","The overall objectives of this BETRNet Research Center (RC) are:\n\n1. to conduct a rigorous, integrated spectrum of transdisciplinary human research in Barrett's esophagus (BE) and esophageal adenocarcinoma (ECA)\n2. to increase the biological understanding of key observations made by our clinical researchers;\n3. 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;\n4. to foster a transdisciplinary and translation research culture and to effectively expand and enhance scientific research focused on BE and EAC;\n5. 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.",[303,304],"Barrett's Esophagus","Esophageal Neoplasm",[303],"2025-07-16",{"date":308,"type":309},"2025-07-18","ACTUAL",{"date":311,"type":309},"2005-10-01",{"date":313,"type":299},"2028-07-31",{"name":5,"class":6},10]