[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445481":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":180,"collaborators":10,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":184,"sex":190,"minAge":191,"maxAge":10,"enrollmentInfo":192,"targetDuration":10,"studyType":195,"phases":10,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Pacific Edge Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm - Patients undergoing surveillance for UC recurrence",null,"Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Low-, intermediate-, and high-risk groups, according to AUA \u002FSUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.",[13],"Diagnostic Test: CxBladder Monitor\u002FMonitor+",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","CxBladder Monitor\u002FMonitor+","CxBladder Monitor\u002FMonitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.",[9],[21],{"name":22,"affiliation":23,"role":24},"Tony Lough","Pacific Edge Pty Ltd","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Donna Smith, MSc (Hons)","CONTACT","+64 21 243 6696","donna.smith@pacificedgedx.com",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Alexis White","+64 21 959 001","alexis.white@pelnz.com",[36,60,80,100,117,138,158],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Miami VA Healthcare System","RECRUITING","Miami","Florida","33125","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-80.19366,25.77427,{"lat":48,"lon":47},[51,54,57],{"name":52,"role":28,"phone":10,"phoneExt":10,"email":53},"Brittney Vail","brittneyvail@va.gov",{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Thomas Masterson","PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":10,"phoneExt":10,"email":10},"Mona Jahromi","SUB_INVESTIGATOR",{"facility":61,"status":38,"city":62,"state":40,"zip":63,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"James A. Haley Veteran's Hospital","Tampa","33612",{"type":45,"coordinates":65},[66,67],-82.45843,27.94752,{"lat":67,"lon":66},[70,75,78],{"name":71,"role":28,"phone":72,"phoneExt":73,"email":74},"Rebecca Reinhard","813-972-2000","6986","Rebecca.Reinhard@va.gov",{"name":76,"role":28,"phone":72,"phoneExt":73,"email":77},"Lauren Deland","Lauren.Deland@va.gov",{"name":79,"role":56,"phone":10,"phoneExt":10,"email":10},"Cesar Ercole",{"facility":81,"status":38,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Ralph H. Johnson VA Health Care System","Charleston","South Carolina","29401",{"type":45,"coordinates":86},[87,88],-79.93275,32.77632,{"lat":88,"lon":87},[91,95,98],{"name":92,"role":28,"phone":93,"phoneExt":10,"email":94},"Penny Hukee","843-789-7816","Penny.Hukee@va.gov",{"name":96,"role":28,"phone":93,"phoneExt":10,"email":97},"Elina Bolukbasi","Elina.Bolukbasi@va.gov",{"name":99,"role":56,"phone":10,"phoneExt":10,"email":10},"Stephen Savage",{"facility":101,"status":38,"city":102,"state":103,"zip":104,"country":42,"countryCode":43,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":45,"coordinates":106},[107,108],-96.80667,32.78306,{"lat":108,"lon":107},[111,115],{"name":112,"role":28,"phone":113,"phoneExt":10,"email":114},"Phillip McDuffie","214-645-8791","Phillip.McDuffie@UTSouthwestern.edu",{"name":116,"role":56,"phone":10,"phoneExt":10,"email":10},"Yair Lotan",{"facility":118,"status":38,"city":119,"state":120,"zip":121,"country":42,"countryCode":43,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"White River Junction Veterans Affair Medical Center","White River Junction","Vermont","05009",{"type":45,"coordinates":123},[124,125],-72.31926,43.64896,{"lat":125,"lon":124},[128,133,136],{"name":129,"role":28,"phone":130,"phoneExt":131,"email":132},"Barbara Timian","(802) 295-9363","5562","Barbara.Timian@va.gov",{"name":134,"role":28,"phone":10,"phoneExt":10,"email":135},"Laura Jensen","Laura.Jensen@va.gov",{"name":137,"role":56,"phone":10,"phoneExt":10,"email":10},"Florian Schroeck, MD",{"facility":139,"status":38,"city":140,"state":141,"zip":142,"country":42,"countryCode":43,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"University of Washington School of Medicine","Seattle","Washington","98195",{"type":45,"coordinates":144},[145,146],-122.33207,47.60621,{"lat":146,"lon":145},[149,153,156],{"name":150,"role":28,"phone":151,"phoneExt":10,"email":152},"Holly Covert","(206) 616 5170","coverh@uw.edu",{"name":154,"role":28,"phone":10,"phoneExt":10,"email":155},"Nita han","nitahan@uw.edu",{"name":157,"role":56,"phone":10,"phoneExt":10,"email":10},"Jonathan Wright, MD",{"facility":159,"status":38,"city":160,"state":161,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Monash Health - Moorabbin Hospital","Clayton","Victoria","3165","Australia","AU",{"type":45,"coordinates":166},[167,168],145.11667,-37.91667,{"lat":168,"lon":167},[171,175,178],{"name":172,"role":28,"phone":173,"phoneExt":10,"email":174},"Nandini Atul Kumar Patel","+61 3 99288750","UrologyResearch@monashhealth.org",{"name":176,"role":28,"phone":173,"phoneExt":10,"email":177},"Sue Mosley","urologyresearch@monashhealth.org",{"name":179,"role":56,"phone":10,"phoneExt":10,"email":10},"Weranja Ranasinghe",{"type":181,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100445481","longitudinal-bladder-cancer-study-for-tumour-recurrence-100445481",false,"NCT05080998","Longitudinal Bladder Cancer Study for Tumour Recurrence","An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients","LOBSTER","Inclusion Criteria:\n\n1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.\n2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit.\n3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible).\n4. Able to give written informed consent\n5. Able and willing to comply with study requirements\n6. Aged 18 years or older\n\nExclusion Criteria:\n\n1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits\n2. Previous muscle invasive bladder tumour (pT2 or greater)\n3. Known pregnancy\n\nDeferral Criteria\n\n1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.\n2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.\n3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.","ALL","18 Years",{"count":193,"type":194},450,"ESTIMATED","OBSERVATIONAL","Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.",[198],"Urothelial Bladder Cancer",[200],"Recurrence","2025-11-06",{"date":203,"type":204},"2025-11-10","ACTUAL",{"date":206,"type":204},"2022-06-08",{"date":208,"type":194},"2026-08-31",{"name":5,"class":6},7]