[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653352":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":62,"studyPopulation":66,"armGroups":67,"interventions":62,"overallOfficials":71,"centralContacts":75,"locations":81,"responsibleParty":95,"collaborators":62,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":62,"enrollmentInfo":107,"targetDuration":62,"studyType":110,"phases":62,"briefSummary":111,"conditions":112,"keywords":62,"overallStatus":84,"whyStopped":62,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Janssen-Cilag Farmaceutica Ltda.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":62},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Treatment Patterns: Type of Therapeutic Approach","Number of participants receiving different types of therapeutic approach including bacillus calmette-guerin (BCG) therapy, chemotherapy, radiotherapy, immunotherapy, or targeted therapy will be reported.","Up to 5 years",{"measure":14,"description":15,"timeFrame":12},"Treatment Patterns: Type of Surgery","Number of participants undergoing different types of surgery, including transurethral resection of the bladder tumor (TURBT), repeat TURBT or cystectomy will be reported.",{"measure":17,"description":18,"timeFrame":12},"Treatment Patterns by Subpopulation: Tumor Stage","Number of participants by tumor stage will be reported.",{"measure":20,"description":21,"timeFrame":12},"Treatment Patterns by Subpopulation: Histology","Number of participants by histology will be reported.",{"measure":23,"description":24,"timeFrame":12},"Treatment Patterns by Subpopulation: Line of Therapy","Number of participants by line of therapy will be reported,",[26,29,32,35,38,41,44,47,50,53,56,59],{"measure":27,"description":28,"timeFrame":12},"Total Number of BCG Doses Administered","Total number of BCG doses administered will be reported.",{"measure":30,"description":31,"timeFrame":12},"Percentage of Participants With BCG Non-Responsive Disease","Percentage of participants with BCG non-responsive disease will be reported. This is defined as being one of the following: a) Persistent or recurrent carcinoma in situ (CIS) alone or with recurrent Ta\u002FT1 (noninvasive papillary disease\u002Ftumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy (defined as at least 5 of 6 induction doses, plus at least 2 of 3 maintenance doses or a second induction). b) Recurrent high-grade Ta\u002FT1 disease within 6 months of completion of adequate BCG therapy. c) T1 high-grade disease at the first evaluation following an induction BCG course.",{"measure":33,"description":34,"timeFrame":12},"Reasons for BCG Interruption","Number of participants with reasons for BCG interruption will be reported.",{"measure":36,"description":37,"timeFrame":12},"Therapy Choice at Recurrence","Therapy choice at recurrence for participants will be reported.",{"measure":39,"description":40,"timeFrame":12},"Recurrence-Free Survival (RFS)","RFS is defined as the time from the date of first treatment initiation for high-risk non-muscle invasive bladder cancer (HR-NMIBC) to the first documented recurrence of high-risk disease, death due to any cause, or censoring, whichever occurs first.",{"measure":42,"description":43,"timeFrame":12},"Progression-Free Survival (PFS)","PFS is defined as the time from the date of first treatment initiation for HR-NMIBC to the first documentation of disease progression, death from any cause, or censoring, whichever occurs first.",{"measure":45,"description":46,"timeFrame":12},"Overall Survival (OS)","OS is defined as the time from the date of first treatment initiation for HR-NMIBC to death from any cause or censoring, whichever occurs first.",{"measure":48,"description":49,"timeFrame":12},"Metastasis-Free Survival (MFS)","MFS is defined as the time from the date of first treatment initiation for HR-NMIBC to the occurrence of distant metastasis, death from any cause, or censoring, whichever occurs first.",{"measure":51,"description":52,"timeFrame":12},"Time to Next Treatment (TTNT)","TTNT is defined as the time from the date of first treatment initiation for HR-NMIBC to the initiation of the next line of treatment or censoring.",{"measure":54,"description":55,"timeFrame":12},"Time on Treatment (TOT)","TOT is defined as the duration between the first and last administration of the treatment.",{"measure":57,"description":58,"timeFrame":12},"Complete Response Rate (CR)","Complete response is defined as the absence of detectable bladder cancer at 6 months after completion of treatment, as confirmed by cystoscopic evaluation and optionally complemented by urine cytology.",{"measure":60,"description":61,"timeFrame":12},"Number and Type of Healthcare Resource Utilization Related to HR-NMIBC","Number and type of healthcare resource utilization related to HR-NMIBC, including procedures, hospitalizations and outpatient visits will be reported.",null,{"allocation":62,"interventionModel":62,"interventionModelDescription":62,"primaryPurpose":62,"observationalModel":64,"timePerspective":65,"maskingInfo":62},"COHORT","RETROSPECTIVE","The study population includes the participants from Portuguese hospitals that treat and manage High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in routine clinical practice.",[68],{"label":69,"type":62,"description":70,"interventionNames":62},"HR-NMIBC Participants: Portuguese Routine Practice","Participants diagnosed with high-risk non-muscle-Invasive bladder cancer (HR-NMIBC) in Portugal between January 1, 2016 and December 31, 2020, with tumor stage N0\u002Fx and M0\u002Fx and one of the following: Tis (primary CIS), TaG3\u002FHG, or T1 will be enrolled. Demographic and clinical information will be gathered from both electronic and paper records for each participant. Only data available within routine clinical practice from the diagnosis until, at least, 5 years after diagnosis will be collected in this study. No drug will be administered as a part of this study.",[72],{"name":73,"affiliation":5,"role":74},"Janssen-Cilag Farmaceutica Ltda. Clinical Trial","STUDY_DIRECTOR",[76],{"name":77,"role":78,"phone":79,"phoneExt":62,"email":80},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[82],{"facility":83,"status":84,"city":85,"state":62,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":62},"Ipo Lisboa","RECRUITING","Lisbon","1099-023","Portugal","PT",{"type":90,"coordinates":91},"Point",[92,93],-9.1498,38.72509,{"lat":93,"lon":92},{"type":96,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100653352","a-study-to-characterize-high-risk-non-muscle-invasive-bladder-cancer-participants-in-portugal-100653352",false,"NCT07784387","A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal","High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study","BRITE","Inclusion criteria:\n\n* Bladder cancer diagnosis between January 1, 2016 and December 31, 2020\n* Tumor stage N0\u002Fx and M0\u002Fx plus any of the following: Tis (primary CIS); TaG3\u002FHG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)\n* Minimal follow-up time of 5 years unless there is premature death event\n\nExclusion criteria:\n\n* Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1\n* History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC\n* Participation in any interventional clinical trial during the observation period","ALL","18 Years",{"count":108,"type":109},250,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.",[113],"Urinary Bladder Neoplasms","2026-08-20",{"date":116,"type":117},"2026-08-25","ACTUAL",{"date":119,"type":109},"2026-08-31",{"date":121,"type":109},"2028-02-29",{"name":5,"class":6},1]