[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592404":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with malignant disease",null,"Will include 30 patients with tumor pathology (10 non-muscle-invasive and 20 muscle-invasive) in which urine samples will be analyzed and, tissue from radical cystectomy samples, will be used to evaluate the urinary microbiome.",[13],"Other: Investigating differences in the bladder microbiome",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-pathological control subjects\u002F\"healthy\" controls","Healthy controls will be selected from men with an age within the above-mentioned range, not affected by urinary pathology and\u002For other overt pathology.\n\nSuitable controls will be recruited from the institution's staff and\u002For visiting for occupational medicine.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control patients with \"benign\" pathologies","This cohort will include individuals with renal cysts, benign prostatic obstruction, ureteropyelic or ureteral obstruction, undergoing surgical therapy.\n\nThe same exclusion criteria as cohort 2 apply.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Investigating differences in the bladder microbiome","Urine samples and tissue from radical cystectomy specimens will be analyzed for the assessment of the urinary microbiome.\n\nThe 16s rRNA gene will be amplified and the resulting amplicons analyzed by Illumina sequencing. To distinguish contaminants, DNA from the sample will be quantified by qPCR and compared to a known urine sample of E. coli. DNA will be extracted using the Quiagen kit and stored at -20 °C until PCR amplification. Bacterial DNA will be amplified with specific primers covering the V1-V3 hypervariable region of the 16S rRNA gene. Libraries will be prepared using the Illumina 16S microbiome sequencing protocol, and their quality will be verified by Bioanalyzer and quantity by qPCR. Sequencing will be performed in \"paired-end\" mode on Illumina sequencers. Alpha, beta diversity and species richness will be measured.",[19,15,9],[28],{"name":29,"affiliation":30,"role":31},"Giuseppe Simone, Doctor","IRCCS National Cancer Institute","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+39-06-5266.5005","+39","giuseppe.simone@ifo.it",[39],{"facility":40,"status":41,"city":42,"state":10,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"\"Regina Elena\" National Cancer Institute","RECRUITING","Rome","00144","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],12.51133,41.89193,{"lat":50,"lon":49},[53,55],{"name":29,"role":34,"phone":54,"phoneExt":36,"email":37},"06-5266.5005",{"name":56,"role":34,"phone":54,"phoneExt":36,"email":57},"Riccardo Mastroianni, Doctor","riccardo.mastroianni@ifo.it",{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100592404","urinary-microbiome-differences-in-bladder-cancer-benign-urinary-diseases-and-healthy-counterparts-in-adult-male-population-100592404",false,"NCT06992986","Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population","Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study","Inclusion Criteria (Bladder Cancer Patients):\n\n* Diagnosis of bladder cancer\n* Negative urine culture\n* Histological confirmation of urothelial carcinoma\n* Patients undergoing radical cystectomy\n\nExclusion Criteria:\n\n* Presence of other neoplasias\n* History of previous BCG therapy\n* Use of indwelling catheter\n* Active antibiotic treatment with two months prior to participation\n* History of sexual transmitted diseases\n* Presence of chronic intestinal inflammation\n* Previous neoadyuvant therapy\n\nInclusion Criteria Controls No-Pathologic\u002FHealthy):\n\n\\- Controls will be collected from men within the specified age range. Eligible controls may be drawn from the institution's personnel attending the occupational medicine department or in service in the Institute.\n\nExclusion Criteria:\n\n* Diabetes\n* Chronic Kidney Disease\n* Cardiac disease\n* Hepatic disease\n\nInclusion Criteria(Benign Urinary Disease)\n\n-To ensure that alterations in the microbiome observed in bladder cancer patients are unique to this condition, an additional group with benign urinary diseases will be included in the analysis. This group will encompass individuals with renal cysts, benign prostatic obstruction, ureteropelvic or ureteral obstruction undergoing surgical therapy.\n\nExclusion Criteria:\n\n* NA",true,"MALE","50 Years","70 Years",{"count":72,"type":73},50,"ESTIMATED","OBSERVATIONAL","The study aims to investigate alterations in the bladder microbiome in adult men with bladder cancer, healthy men, and men with benign urinary disease",[77],"Bladder Cancer","2025-05-19",{"date":80,"type":81},"2025-05-28","ACTUAL",{"date":83,"type":81},"2024-02-06",{"date":85,"type":73},"2025-07-06",{"name":5,"class":6},1]