[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595065":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":14,"centralContacts":19,"locations":29,"responsibleParty":46,"collaborators":10,"id":48,"slug":10,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Reader Group A: Interprets Dataset A in unaided scenario and Dataset B in aided scenario",null,"A reader study with 12 readers (4 Junior Physician, 4 mid-level Physician and 4 Senior Physician) from the Department of Surgical Oncology of the Digestive Tract will be conducted. The readers are equally and randomly split between Group A and Group B. The study will target 166 CRLM patient cases receiving simultaneous resection.Patient cases will be equally and randomly split between Dataset A and Dataset B.",{"label":13,"type":10,"description":11,"interventionNames":10},"Reader Group B: Interprets Dataset A in aided scenario and Dataset B in unaided scenario",[15],{"name":16,"affiliation":17,"role":18},"Hong Zhao, MD","Cancer Hospital Chinese Academy of Medical Science","PRINCIPAL_INVESTIGATOR",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"HONG ZHAO, MD","CONTACT","+8613381106850","zhaohong@cicams.ac.cn",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Qichen Chen, MD","+8618810550822","chenqichen0822@126.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"No. 17, South Panjiayuan, Chaoyang District, Beijing, Cancer Hospital, Chinese Academy of Medical Sciences, China","RECRUITING","Beijing","Beijing Municipality","100021","China",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":21,"role":22,"phone":45,"phoneExt":10,"email":24},"01087788224",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100595065",false,"NCT07027605","Multi-Reader Multi-Case Trial Evaluating Computer-Aided Tool for Prognostic Prediction of Colorectal Liver Metastases","A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Performance Improvement From Computer-aided Tool for the Prognostic Prediction of Colorectal Liver Metastases","Inclusion Criteria:\n\n* ≥ 18 years old\n* confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma\n* receiving colorectal resection with simultaneous liver resection.\n\nExclusion Criteria:\n\n* presence of other malignancies\n* absence of follow-up data\n* patients who were followed up postoperatively for less than 5 years and had no occurrences of death.","ALL","18 Years",{"count":57,"type":58},166,"ESTIMATED","OBSERVATIONAL","This study evaluates the impact of a novel computer-aided prognostic prediction tool for colorectal liver metastases (CRLM) on clinician performance. Colorectal cancer is a leading cause of cancer-related mortality worldwide, with 20-30% of patients presenting synchronous liver metastases, which are associated with poor prognosis and high postoperative recurrence rates. Simultaneous resection of primary tumor and liver metastases is a preferred treatment for selected patients but outcomes vary significantly. The latest web-based tool uses Random Forest models integrating demographic, clinical, laboratory, and genetic data to predict postoperative recurrence and mortality specifically for CRLM patients undergoing simultaneous resection. This multiple-reader, multiple-case (MRMC) study will assess 12 physicians who will predict 1-, 3-, and 5-year recurrence and mortality risks in 166 retrospective cases, with and without the tool's aid, separated by a washout period. The primary focus is to determine whether the tool improves prediction accuracy for 3-year postoperative mortality, measured by AUC-ROC. Secondary and exploratory endpoints include other time points, sensitivity, specificity, inter-rater reliability, decision-making confidence, and evaluation time. By enabling individualized risk assessment, this tool aims to support optimized clinical decision-making and tailored treatment strategies for CRLM patients undergoing simultaneous resection.",[62],"Colorectal Liver Metastasis (CRLM)",[64,65,66],"Multi-Reader Multi-Case Controlled Clinical Trial","Prognostic Prediction","Colorectal Liver Metastases","2025-08-17",{"date":69,"type":70},"2025-08-19","ACTUAL",{"date":72,"type":70},"2025-01-01",{"date":74,"type":58},"2025-09-25",{"name":5,"class":6},1]