[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100418008":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":20,"locations":30,"responsibleParty":43,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Mansoura University","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"High risk NMIBC","Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered",[12,13],"Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10)","Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis",[15,21],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Urine ELISA for immunological markers (IL-2 and IL-10)","IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively",[9],null,{"type":16,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis","blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 μg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control",[9],[26],{"name":27,"affiliation":28,"role":29},"Amr A Elsawy","Urology and Nephrology Center","PRINCIPAL_INVESTIGATOR",[31],{"facility":28,"status":20,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":20},"Al Mansurah","DK","35516","Egypt","EG",{"type":38,"coordinates":39},"Point",[40,41],31.38069,31.03637,{"lat":41,"lon":40},{"type":29,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Amr Abdel-Lateif El-Sawy","Principal Investigator","100418008","can-we-predict-of-the-response-of-high-risk-non-muscle-invasive-bladder-cancer-patients-to-intravesical-bacillus-calmette-guerin-the-role-of-immunological-markers-100418008",false,"NCT04723121","Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers","Inclusion Criteria:\n\n* patients with primary or recurrent NMIBC for whom primary TURBT was done.\n\nExclusion Criteria:\n\n1. Patients with previous BCG instillation,\n2. benign pathology\n3. Variant histology\n4. Non urothelial carcinoma,\n5. concommitent upper tract urothelial tumors, detrusor muscle invasion\n6. low or intermediate risk NMIBC","ALL","18 Years",{"count":55,"type":56},204,"ACTUAL","INTERVENTIONAL",[59],"NA","Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.\n\nObjectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.",[62],"Bladder Cancer",[64,65,66,67,68,69,70],"Bladder cancer","Bacillus Calmette-Guérin response","Prediction","Urinary cytokines","T cells","Recurrence","Progression","COMPLETED","2021-01-22",{"date":74,"type":56},"2021-01-25",{"date":76,"type":56},"2013-03-01",{"date":78,"type":56},"2020-12-01",{"name":5,"class":6},1]