[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471093":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":39,"overallOfficials":24,"centralContacts":44,"locations":24,"responsibleParty":53,"collaborators":57,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":32,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":24,"briefSummary":74,"conditions":75,"keywords":24,"overallStatus":77,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":24},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic accuracy","area under receiver operating characteristic curves, AUROC in prediction of final histopathology","During the colonoscopy",[14,16,18,20,22],{"measure":15,"description":15,"timeFrame":12},"Sensitivity",{"measure":17,"description":17,"timeFrame":12},"Specificity",{"measure":19,"description":19,"timeFrame":12},"Positive predictive value",{"measure":21,"description":21,"timeFrame":12},"Negative predictive value",{"measure":23,"description":23,"timeFrame":12},"Diagnostic time",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time prediction of histopathology. It can assist endoscopists to select the appropriate technique and differentiate between neoplastic or non-neoplastic polyps. Nevertheless, due to the substantial inter-observer variability, the widespread use was limited.\n\nRecently, artificial intelligence and computer-aided polyp diagnosis (CADx) systems have evolved rapidly. The major limitation was the heterogeneity from different types of imaging modalities. Endocytoscopic images require extra steps for pre-staining and magnification, which are time consuming and operator dependent. As a result, it limits the generalisability and applicability in real-world settings.\n\nA novel CADx system will be developed for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy (NBI). The diagnostic accuracy of this CADx system will be compared with both expert and junior endoscopists.","Patient with colorectal neoplasia",[31,36],{"label":32,"type":24,"description":33,"interventionNames":34},"CADx","Histopathology prediction by CADx device",[35],"Device: CADx",{"label":37,"type":24,"description":38,"interventionNames":24},"Endoscopist","Real-time histopathology prediction by expert and non-expert endoscopists",[40],{"type":41,"name":32,"description":42,"armGroupLabels":43,"otherNames":24},"DEVICE","A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.",[32],[45,50],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},"Felix Sia","CONTACT","26370428","felixsia@cuhk.edu.hk",{"name":51,"role":47,"phone":48,"phoneExt":24,"email":52},"Thomas Lam","thomaslam@cuhk.edu.hk",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Louis Ho Shing Lau","Assitant Professor",[58,60],{"name":59,"class":6},"Nanfang Hospital, Southern Medical University",{"name":61,"class":6},"University College, London","100471093","a-prospective-study-to-evaluate-the-diagnostic-accuracy-of-computer-aided-diagnosis-cadx-system-in-real-time-characterization-of-colorectal-neoplasia-100471093",false,"NCT05414383","A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia","Inclusion Criteria:\n\n1. They have received colonoscopy for screening, surveillance or symptom investigation;\n2. They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;\n3. They have histologically proven colorectal neoplasia.\n4. Written consent obtained\n\nExclusion Criteria:\n\n1. Poor quality endoscopic images and videos defined as:\n\n   1. Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);\n   2. Artifacts due to mucus, air bubbles, stool, or blood.\n2. Active gastrointestinal bleeding;\n3. Fulminant colitis;\n4. Obscured view due to poor bowel preparation;\n5. Artificial staining of lesion due to chromoendoscopy.\n6. Unable to obtain informed consent","ALL","18 Years",{"count":71,"type":72},510,"ESTIMATED","OBSERVATIONAL","The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.",[76],"Colorectal Neoplasms","NOT_YET_RECRUITING","2026-09-21",{"date":80,"type":81},"2026-09-22","ACTUAL",{"date":83,"type":72},"2026-12",{"date":85,"type":72},"2026-12-31",{"name":5,"class":6}]