[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568011":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":10,"centralContacts":39,"locations":10,"responsibleParty":50,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":10},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem\u002FDox.",null,"Predictive role of microbiome in male with low grade non-muscle invasive bladder carcinoma undergoing Gem\u002FDox.",[13],"Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.",{"label":15,"type":10,"description":16,"interventionNames":17},"1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem\u002FDox.","Predictive role of microbiome in female with low grade non-muscle invasive bladder carcinoma undergoing Gem\u002FDox.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC.","Predictive role of microbiome in male with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC.","Predictive role of microbiome in female with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG.","Predictive role of microbiome in male with high grade non-muscle invasive bladder carcinoma undergoing BCG.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG.","Predictive role of microbiome in female with high grade non-muscle invasive bladder carcinoma undergoing BCG.",[13],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.","DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.",[15,9,23,19,31,27],[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Massimo Alfano, PhD","CONTACT","+39-022643","6351","alfano.massimo@hsr.it",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},"Marco Moschini, MD, PhD","9742","moschini.marco@hsr.it",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Massimo Alfano","PhD","100568011","predictive-role-of-microbiome-in-patients-with-urothelial-carcinoma-100568011",false,"NCT06675656","Predictive Role of Microbiome in Patients With Urothelial Carcinoma","Inclusion Criteria:\n\n* Adults aged ≥ 18 years, all able to signed informed consent form;\n* Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.\n\nExclusion Criteria:\n\n* Participants with ongoing urinary tract infection;\n* Antibiotic treatment within the last month;\n* Immuno-\u002Fchemo- therapy within the past 3 months;\n* Chronic immunosuppressive therapy;\n* Additional major diagnosis known to affect the gut or bladder microbiota;\n* Use of probiotics;\n* Uncontrolled diabetes;\n* Participants with other malignancy or previous history of oncological or autoimmune diseases.","ALL","18 Years","99 Years",{"count":64,"type":65},420,"ESTIMATED","OBSERVATIONAL","This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.\n\nIn this prospective cohort study patients with low\u002Fintermediate\u002Fhigh risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG\u002Fchemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.",[69],"Urinary Bladder Cancer","NOT_YET_RECRUITING","2024-11-04",{"date":73,"type":74},"2024-11-05","ACTUAL",{"date":76,"type":65},"2024-11",{"date":78,"type":65},"2035-11",{"name":5,"class":6}]