[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598526":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":27,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EV-based therapy",null,"Patients with locally advanced or metastatic urothelial carcinoma receiving enfortumab vedotin-based therapy",[13],"Diagnostic Test: Neurological function assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Neurological function assessment","Neurological evaluations including neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. Assessments will be conducted at baseline and every three months until six months after completion of EV treatment.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Fu-Jen Hsueh, M.D.","CONTACT","02-23123456","66001","017052@ntuh.gov.tw",[28],{"facility":5,"status":10,"city":29,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Taipei","Taiwan","TW",{"type":33,"coordinates":34},"Point",[35,36],121.52639,25.05306,{"lat":36,"lon":35},[39,40],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},{"name":22,"role":41,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100598526","neurological-function-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-treated-with-enfortumab-vedotin-based-therapy-100598526",false,"NCT07072637","Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy","A Prospective Study Assessing Neurological Function and Its Clinical Implications in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin-Based Therapy","Inclusion Criteria:\n\n1. Age ≥ 20 y\u002Fo\n2. Histologically confirmed urothelial carcinoma\n3. Radiologically documented locally advanced or metastatic disease\n4. Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)\n5. Complete and identifiable medical records\n\nExclusion Criteria:\n\n1. Do not agree to receive regular neurological examinations\n2. Do not agree to provide complete medical records during treatment","ALL","20 Years",{"count":54,"type":55},100,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la\u002FmUC) receiving enfortumab vedotin (EV)-based therapy. A total of 100 patients will be enrolled between March 2025 and December 2029. Eligible participants will undergo comprehensive neurological assessments, including neurological examination(NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These assessments will be conducted at baseline and every three months until six months after completion of EV-based therapy. Patient characteristics and oncological outcomes will also be collected. This study seeks to identify risk factors for developing PN and to explore the clinical implications of EV-associated neurological changes, with the ultimate goal of optimizing treatment strategies and improving quality of life.",[59],"Locally Advanced or Metastatic Urothelial Carcinoma",[61,62,63],"enfortumab vedotin","urothelial carcinoma","neurological function","NOT_YET_RECRUITING","2025-07-09",{"date":67,"type":68},"2025-07-18","ACTUAL",{"date":70,"type":55},"2025-07",{"date":72,"type":55},"2031-12-31",{"name":5,"class":6},1]