[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651591":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Systemic Therapy Followed by Radical Cystectomy","ACTIVE_COMPARATOR","Participants receive standard-of-care neoadjuvant systemic therapy, as selected by the treating physician, followed by radical cystectomy with urinary diversion.\n\nInterventions: Each specific drug regimen confirmed by the PI, plus Radical Cystectomy With Urinary Diversion.",[13,14],"Drug: Neoadjuvant Therapy","Procedure: Upfront radical cystectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Upfront Radical Cystectomy","EXPERIMENTAL","Participants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy.\n\nIntervention: Radical Cystectomy With Urinary Diversion",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Neoadjuvant Therapy","Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Upfront radical cystectomy","Patients will undergo upfront radical cystectomy without neoadjuvant therapy",[9,16],[33],{"name":34,"affiliation":35,"role":36},"Saum Ghodoussipour, MD","Rutgers University","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","732-235-2465","sg1621@cinj.rutgers.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Rutgers Cancer Institute","RECRUITING","New Brunswick","New Jersey","08901","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.45182,40.48622,{"lat":55,"lon":54},[58],{"name":34,"role":39,"phone":59,"phoneExt":26,"email":41},"732-235-5265",{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Saum Ghodoussipour","Director, Bladder and Urothelial Cancer Program, Rutgers Cancer Institute","100651591","phase-2-luminal-bladder-cancer-effective-response-to-neoadjuvant-chemotherapy-lumber-nac-100651591",false,"NCT07762586","Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)","Inclusion Criteria:\n\n* ▪ Inclusion Criteria\n\n  * Willing and able to provide informed consent\n  * Age ≥18 years old\n  * Eligible to receive standard of care systemic neoadjuvant therapy\n  * Eastern Cooperative Group (ECOG) performance status of 0-1\n  * Documented histologically confirmed urothelial muscle-invasive bladder cancer\n  * cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT.\n  * Willing to undergo RC with urinary diversion\n  * No signs of extravesical disease on pre-TURBT conventional imaging\n  * Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma.\n  * No presence of LVI on TURBT\n  * Decipher Bladder GSC test result\n  * Ineligible for or refusing TMT\n  * No cN+\n  * The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer.\n\nExclusion Criteria:\n\n* Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.\n* Not willing or unable to give informed consent.\n* Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.\n* Significant hepatic impairment (Serum bilirubin \\> 1.5x upper limit of normal).\n* Significant renal impairment (creatinine clearance \\\u003C30 ml\u002Fmin).\n* Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6\n* cT3 bladder cancer on pre-TURBT bimanual exam or with hydronephrosis on cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT\n* TURBT specimen with lymphovascular invasion (LVI) cT4 or unresectable bladder cancer\n* Concurrent diagnoses of other, non-urothelial, malignancies or prior malignancy diagnoses within the past three years. Exceptions, determined at the discretion of the principal investigator, include squamous cell carcinoma, basal cell carcinoma, or other low-grade cancer not expected to progress or require surgical\u002Fsystemic therapy.\n* Prior history of systemic treatment for non-urothelial malignancies in the past three years, including chemotherapy and immunotherapy.\n* Prior diagnosis or evidence of psychiatric or medical conditions that may prevent patients from giving full and properly informed consent.\n* Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol\n* Patients (cN+) are excluded from participation and are not eligible for enrollment.\n* Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.","ALL","18 Years","90 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.",[80],"Bladder Cancer","2026-08-07",{"date":83,"type":84},"2026-08-13","ACTUAL",{"date":86,"type":84},"2026-07-10",{"date":88,"type":74},"2029-07",{"name":5,"class":6},1]