[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627960":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":203,"collaborators":205,"id":234,"slug":235,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":236,"sex":242,"minAge":243,"maxAge":18,"enrollmentInfo":244,"targetDuration":18,"studyType":247,"phases":248,"briefSummary":250,"conditions":251,"keywords":257,"overallStatus":273,"whyStopped":18,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Participants in the intervention arm will be informed by the investigator on their genetic risk profile.",[13],"Other: Risk profile disclosure",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Participants in the control arm will not be informed by the investigator on their genetic risk profile. Both the participant and the investigator are not aware of the genetic risk profile.",null,[20],{"type":6,"name":21,"description":11,"armGroupLabels":22,"otherNames":18},"Risk profile disclosure",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Martin Wyckmans, Resident Physician","CONTACT","+323 821 32 80","martin.wyckmans@uza.be",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},"Luka Van der Veken, Master Biomedical Sciences","+3234368249","luka.vanderveken@uza.be",[34,47,62,77,92,109,127,145,163,182],{"facility":35,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":18},"Antwerp University Hospital","Edegem","Antwerpen","2650","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],4.44504,51.15662,{"lat":45,"lon":44},{"facility":48,"status":18,"city":49,"state":37,"zip":50,"country":39,"countryCode":40,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Sint-Augustinus Hospital (ZAS)","Wilrijk","2610",{"type":42,"coordinates":52},[53,54],4.39513,51.16734,{"lat":54,"lon":53},[57,59],{"name":58,"role":26,"phone":27,"phoneExt":18,"email":28},"Martin Wyckmans",{"name":60,"role":61,"phone":18,"phoneExt":18,"email":18},"Thomas Botelberge","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":18,"city":64,"state":39,"zip":65,"country":39,"countryCode":40,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Ghent University Hospital (UZ Gent)","Ghent","9000",{"type":42,"coordinates":67},[68,69],3.71667,51.05,{"lat":69,"lon":68},[72,76],{"name":73,"role":26,"phone":74,"phoneExt":18,"email":75},"David Tate","0032 9 332 23 00","david.tate@uzgent.be",{"name":73,"role":61,"phone":18,"phoneExt":18,"email":18},{"facility":78,"status":18,"city":79,"state":39,"zip":80,"country":39,"countryCode":40,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"AZ Delta","Roeselare","8800",{"type":42,"coordinates":82},[83,84],3.12269,50.94653,{"lat":84,"lon":83},[87,91],{"name":88,"role":26,"phone":89,"phoneExt":18,"email":90},"Dominiek Dewulf","+32 51 23 72 15","dominiek.dewulf@azdelta.be",{"name":88,"role":61,"phone":18,"phoneExt":18,"email":18},{"facility":93,"status":18,"city":94,"state":18,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Rigshospitalet","Copenhagen","2100","Denmark","DK",{"type":42,"coordinates":99},[100,101],12.56553,55.67594,{"lat":101,"lon":100},[104,108],{"name":105,"role":26,"phone":106,"phoneExt":18,"email":107},"Prof. Dr. Michael Patrick Achiam","+45 35 45 04 41","michael.patrick.achiam.01@regionh.dk",{"name":105,"role":61,"phone":18,"phoneExt":18,"email":18},{"facility":110,"status":18,"city":111,"state":18,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"CHU LILLE - Centre Hospitalier Universitaire de Lille","Lille","59000","France","FR",{"type":42,"coordinates":116},[117,118],3.05512,50.63391,{"lat":118,"lon":117},[121,125],{"name":122,"role":26,"phone":123,"phoneExt":18,"email":124},"Florence Nosal","+33320445751","florence.nosal@chru-lille.fr",{"name":126,"role":61,"phone":18,"phoneExt":18,"email":18},"Guillaume Piessen",{"facility":128,"status":18,"city":129,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"University Hospital Leipzig","Leipzig","04103","Germany","DE",{"type":42,"coordinates":134},[135,136],12.37129,51.33962,{"lat":136,"lon":135},[139,143],{"name":140,"role":26,"phone":141,"phoneExt":18,"email":142},"Dr. René Thieme","+49 341 97 20809","rene.thieme@medizin.uni-leipzig.de",{"name":144,"role":61,"phone":18,"phoneExt":18,"email":18},"René Thieme",{"facility":146,"status":18,"city":147,"state":18,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"St James's Hospital","Dublin","D08 NHY1","Ireland","IE",{"type":42,"coordinates":152},[153,154],-6.24889,53.33306,{"lat":154,"lon":153},[157,161],{"name":158,"role":26,"phone":159,"phoneExt":18,"email":160},"Prof. Jacintha O'Sullivan","+353 1 8962149","OSULLIJ4@tcd.ie",{"name":162,"role":61,"phone":18,"phoneExt":18,"email":18},"Jessie Elliot",{"facility":164,"status":18,"city":165,"state":166,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"IRCCS Ospedale San Raffaele","Milan","Milano","20132","Italy","IT",{"type":42,"coordinates":171},[172,173],12.59836,42.78235,{"lat":173,"lon":172},[176,180],{"name":177,"role":26,"phone":178,"phoneExt":18,"email":179},"Dr. Federica Ungaro","+39 0226437864","Ungaro.Federica@hsr.it",{"name":181,"role":61,"phone":18,"phoneExt":18,"email":18},"Federica Ungaro",{"facility":183,"status":18,"city":184,"state":18,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Karolinska University Hospital","Solna","SE-171 76","Sweden","SE",{"type":42,"coordinates":189},[190,191],18.00086,59.36004,{"lat":191,"lon":190},[194,198,201],{"name":195,"role":26,"phone":196,"phoneExt":18,"email":197},"Dr. Fredrik Klevebro","+46-8-585 800 00","fredrik.klevebro@regionstockholm.se",{"name":199,"role":26,"phone":18,"phoneExt":18,"email":200},"Dr. Henrik Maltzman","henrik.maltzman@regionstockholm.se",{"name":202,"role":61,"phone":18,"phoneExt":18,"email":18},"Fredrik Klevebro",{"type":204,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[206,208,209,211,214,216,217,219,221,223,225,227,229,230,232],{"name":207,"class":6},"Karolinska Institutet",{"name":183,"class":6},{"name":210,"class":6},"Amsterdam UMC",{"name":212,"class":213},"Radbound University Medical Center","UNKNOWN",{"name":215,"class":6},"University of Leipzig",{"name":164,"class":6},{"name":218,"class":6},"University of Dublin, Trinity College",{"name":220,"class":6},"St. James's Hospital, Ireland",{"name":222,"class":6},"Heinrich-Heine University, Duesseldorf",{"name":224,"class":6},"Rigshospitalet, Denmark",{"name":226,"class":6},"Universitätsklinikum Leipzig",{"name":228,"class":6},"GZA Ziekenhuizen Campus Sint-Augustinus",{"name":78,"class":6},{"name":231,"class":6},"University Hospital, Lille",{"name":233,"class":6},"University Hospital, Ghent","100627960","a-study-of-barretts-esophagus-patients-optimization-of-a-risk-model-to-better-predict-the-development-of-cancer-recurrence-and-the-effect-of-risk-profile-disclosure-on-patient-quality-of-life-and-fear-of-cancer-100627960",false,"NCT07455422","A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer","A Randomized Controlled Trial Using Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early ESOPHAGEAL ADENOCARCINOMA for Assessing Effects on Quality of Life, Cancer Worry and Defining Cost-Effective Surveillance Strategies","Endeavor-2","Inclusion Criteria:\n\n* Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal Barrett cancer\n* Capable of receiving informed consent and of giving permission\n* Age 18 and upward\n\nExclusion Criteria:\n\n* Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion\n* Patients refusing randomization and corresponding follow-up intervals based on biomarker profile\n* Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)\n* Esophageal varices\n* Uncontrollable coagulation disorders\n* Undergoing\u002Fplanned chemotherapy or immunotherapy or received chemotherapy \\\u003C 6 months prior to endoscopy\n* Undergoing\u002Fplanned radiotherapy within the esophageal region or received radiotherapy \\\u003C 6 months prior to endoscopy\n* WHO score \\>3","ALL","18 Years",{"count":245,"type":246},266,"ESTIMATED","INTERVENTIONAL",[249],"NA","The goal of the study is:\n\n* The collection of various tissue samples (blood, biopsies and \"esophageal brushes\") and their analysis.\n* To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples.\n* Evaluating the quality of life of Barrett's Esophagus patients and the degree of fear of getting cancer.\n\nPatients with a Barrett's Esophagus can participate in the study if they are minimally 18 years old, are capable of giving informed consent (fully understanding what the study entails before giving consent to participate), have Barrett Esophagus and are referred to one of the participating centers due to suspicion of early esophageal cancer, for which the participant will be evaluated by endoscopic imaging and biopsy.\n\nStudy procedures:\n\nAn intake consultation will be planned, wherein the eligibility criteria will be assessed, and participant characteristics will be collected.\n\nA routine gastroscopy will be planned twice during which several minimally-invasive interventions will be performed: drawing a blood sample, brush cytology during the endoscopy (a brush is used to obtain cells from the surface of the esophagus) and obtaining biopsy samples (small pieces of tissue). Each participant will need to undergo all the interventions.\n\nPatients will have to complete questionnaires at several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).\n\nThis study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.",[252,253,254,255,256],"Barrett Esophagus","Barrett Esophagus Adenocarcinoma","Adenocarcinoma - GEJ","Gastroenterology","Gastroenterological Cancer",[252,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272],"Barrett","DNA FISH","Genetic profiling","Adenocarcinoma","Brush cytology","Cancer worry","Disease free survival","Randomized controlled trial","RCT","Endoscopic mucosal resection","Endoscopic submucosal dissection","EMR","ESD","Quality of life","Health-Economic analysis","NOT_YET_RECRUITING","2026-03-02",{"date":276,"type":277},"2026-03-06","ACTUAL",{"date":279,"type":246},"2026-06-01",{"date":281,"type":246},"2030-12-31",{"name":5,"class":6},10]