[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411775":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":54,"collaborators":10,"id":56,"slug":10,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A",null,"Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers.",[13],"Other: No intervention required",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B","Validation cohort will be recruited in the next 36 months of the study period.",[13],[19],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":10},"No intervention required",[9,15],[23],{"name":24,"affiliation":25,"role":26},"Yeong Shiau Pu, MD PhD","Department of Urology, National Taiwan University Hospital","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","886-2-23123456","65254","pu5249@ntuh.gov.tw",{"name":34,"role":29,"phone":30,"phoneExt":35,"email":36},"Chung Hsin Chen, MD PhD","65242","mufasachen@gmail.com",[38],{"facility":5,"status":39,"city":40,"state":10,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Taipei","100","Taiwan",{"type":44,"coordinates":45},"Point",[46,47],121.52639,25.05306,{"lat":47,"lon":46},[50,52],{"name":51,"role":29,"phone":30,"phoneExt":31,"email":32},"Yeong-Shiau Pu, MD PhD",{"name":53,"role":29,"phone":30,"phoneExt":35,"email":36},"Chung-Hsin Chen, MD PhD",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100411775",false,"NCT04641936","Urine Omics Predicting IO Therapy Responses in mUC Patients","Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n* 1\\. Age \\> 20 years\n* 2\\. Subjects diagnosed as metastatic urothelial carcinoma (mUC)\n* 3\\. Subjects who are about to receive IO-based therapy\n* 4\\. ECOG performance 0, 1, 2, and 3\n* 5\\. Life expectancy 3 months\n* 6\\. eGFR \\> 15 ml\u002Fmin\u002F1.73 m2 (Stage IV Chronic Kidney Disease or better)\n* 7\\. Willing to sign the informed consent form\n\nExclusion Criteria:\n\n* 1\\. Subjects NOT willing to sign the informed consent form\n* 2\\. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \\> 5\u002FHPF\n* 3\\. Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.\n* 4\\. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators\n* 5\\. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.\n* 6\\. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \\>12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.","MALE","20 Years",{"count":65,"type":66},600,"ESTIMATED","OBSERVATIONAL","The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.",[70],"Metastatic Urothelial Carcinoma",[72,73,74,75,76,77,78],"urothelial carcinoma","biomarkers","clinical responses","IO-based therapies","metabolomics","proteomics","Urine","2024-04-15",{"date":81,"type":82},"2024-04-17","ACTUAL",{"date":84,"type":82},"2020-12-17",{"date":86,"type":66},"2027-10-31",{"name":5,"class":6},1]