[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597928":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":50,"collaborators":54,"id":57,"slug":26,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Queen's University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravesical Gemcitabine + BCG","EXPERIMENTAL","Patients will be recruited to treatment with gemcitabine at week 0 following which BCG (50 mg, TICE strain) will be administered once every week for a total of 5 instillations.",[13],"Drug: Gemcitabine + BCG",{"label":15,"type":16,"description":17,"interventionNames":18},"Intravesical Bacillus Calmette-Guérin (BCG)","ACTIVE_COMPARATOR","6 intravesical instillations of BCG (50 mg, TICE strain) at weekly intervals.",[19],"Drug: BCG (TICE strain)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gemcitabine + BCG","Patients will receive a single intravesical instillation of gemcitabine (2000 mg) at week 0 followed by weekly BCG (50 mg of TICE strain) for a total of 5 instillations. Biopsy will be conducted within three months of completing the induction phase.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"BCG (TICE strain)","Patients will receive intravesical BCG (50 mg, TICE strain) at weekly intervals for a total of 6 instillations. Biopsy will be performed within 3 months of completing the induction phase.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"David Robert Siemens, MD","CONTACT","(613) 548-2411","robert.siemens@kingstonhsc.ca",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"Kingston Health Sciences Center","Kingston","Ontario","K7L3N6","Canada",{"type":45,"coordinates":46},"Point",[47,48],-76.48098,44.22976,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Madhuri Koti","Associate Professor",[55],{"name":56,"class":6},"Queen's University, Kingston, Ontario","100597928",false,"NCT07064863","A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.","BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.","BCG-TIME","Inclusion Criteria:\n\n* Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).\n* Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.\n* Participants older than 65 years of age.\n\nExclusion Criteria:\n\n* Patients with prior exposure to BCG immunotherapy.\n* Immunosuppressed patients on steroids, transplants etc.","ALL","65 Years",{"count":67,"type":68},31,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.",[75,76,77,78],"NMIBC","Non-Muscle Invasive Bladder Urothelial Carcinoma","Bladder (Urothelial, Transitional Cell) Cancer","Urothelial Carcinoma Bladder",[80,75,81,82,83,84,85],"BCG","Gemcitabine","Tumor Immune MicroEnvironment","Systemic immunity","Mucosal immune response","Immune Biomarker","NOT_YET_RECRUITING","2025-07-14",{"date":89,"type":90},"2025-07-17","ACTUAL",{"date":92,"type":68},"2025-08-01",{"date":94,"type":68},"2027-07-31",{"name":5,"class":6},1]