[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-bladder-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-bladder-diseases":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100534368","phase-2-stage-ii-iiia-urothelial-cancer-randomizing-pre-operative-nivolumab-with-or-without-relatlimab-100534368",false,"NCT06237920","Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab","TURANDORELA","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Age ≥ 18 years\n* Resectable muscle-invasive UC of the bladder, defined as cT2-4aN0M0 OR cT1-4aN1M0. In cT1N1 patients, lymph node positivity would need to be cytologically or histologically confirmed.\n* Surgical resection (cystectomy) is the advised locoregional treatment and is accepted by the subject after consultation with the urologist.\n* Patients are either cisplatin ineligible or elect to not undergo cisplatin based neoadjuvant chemotherapy after a balanced discussion of risks and benefits with the treating physician. Cisplatin eligibility is determined based on the Galsky criteria\n* World Health Organization (WHO) performance Status 0 or 1.\n* Urothelial cancer is the dominant histology (\\>50%). Any component of small cell or adenocarcinoma is not allowed.\n* Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Platelets ≥100 x109\u002FL, Hemoglobin ≥5.5 mmol\u002FL, GFR\\>30 ml\u002Fmin, AST ≤ 1.5 x ULN, ALT ≤1.5 x ULN, Bilirubin ≤1.5 X ULN\n* Negative pregnancy test (βHCG in blood or urine) within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.\n* Highly effective contraception for female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol (→ 8.2.1 Pregnancy, contraception and breastfeeding)\n\nExclusion Criteria:\n\n* Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included.\n* Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis).\n* Previous intravenous systemic therapy or radiotherapy for UC.\n* Upper urinary tract disease, unless all disease is planned to be resected in the same surgery as for UBC. This includes non-muscle-invasive disease.\n* Prior CTLA-4, LAG3 or PD-1\u002FPD-L1-targeting immunotherapy.\n* Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n* HIV-positive patients are eligible if the following applies:\n* No AIDS defining opportunistic infection within the last year and a current CD4 count \\>350 cells\u002FuL.\n* Received antiretroviral therapy (ART) for at least 4 weeks prior to treatment and continued while enrolled on study\n* CD4 counts and viral load are monitored per standard of care by a local health care provider\n* In patients with a known history of hepatitis B or hepatitis C infection, Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) should be negative\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples may include severe pulmonary disease with extensive radiological abnormalities or intestinal disease causing severe diarrhea, not covered by other eligibility criteria, that may obscure colitis.\n* Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed.\n* Use of other investigational drugs before study drug administration.\n* Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated \\>10%). Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n* Pregnant and lactating female patients.\n* Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n* Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias and unstable angina.","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment",[27,28,29,30,31,32,33,34,35,36,37],"Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Urinary Bladder Diseases","Male Urogenital Diseases","Urinary Bladder Neoplasm","Antineoplastics Toxicity",[39,40],"Nivolumab","Relatlimab","RECRUITING","2025-09-01",{"date":44,"type":45},"2025-09-03","ACTUAL",{"date":47,"type":45},"2024-02-19",{"date":49,"type":21},"2028-08-01",{"name":51,"class":52},"The Netherlands Cancer Institute","OTHER",9,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100396486","bladder-fiducial-markers-and-multiparametric-mri-mp-mri-to-optimize-bladder-chemo-radiotherapy-100396486","NCT04442724","Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy","FMBRT","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.\n* Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder\n* Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation\n* Adequate renal function: Serum creatinine \\\u003C 2 mg\u002FdL OR calculated creatinine clearance (CrCl) \\> 30ml\u002Fmin\n* Ability to understand and willingness to sign a written informed consent\n* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation\n\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed\n* Known distant metastatic disease (e.g. pulmonary or hepatic metastases)\n\n  * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed\n* Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)\n* Planned (or prior history of) definitive bladder irradiation\n* Intravesical chemo- or biologic therapy within 6 weeks of first treatment\n* Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion\n* Clinically significant active infection or uncontrolled medical condition that would preclude participation in study\n* Pregnant or nursing women are excluded\n* Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment\n* Individuals with severe renal failure and cannot receive MRI contrast",{"count":62,"type":21},60,[64],"NA","The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.",[67,36,27,30,34],"Bladder Cancer",[69,70],"Fiducial marker","Fiducial marker guided technique","2025-08-11",{"date":73,"type":45},"2025-08-14",{"date":75,"type":45},"2020-07-01",{"date":77,"type":21},"2026-06-30",{"name":79,"class":52},"Cedars-Sinai Medical Center",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100451068","infectious-complications-after-cystectomy-a-prospective-observational-study-100451068","NCT05153694","Infectious Complications After Cystectomy: A Prospective Observational Study","Inclusion Criteria:\n\n* Disease which requires removal of the urinary bladder\n\nExclusion Criteria:\n\n* Patient does not want to participate",{"count":87,"type":21},200,"OBSERVATIONAL","Patients undergoing cystectomy for either oncological or non-oncological indications are prospectively enrolled following informed consent. This study design incorporates a comprehensive medical history, detailed prospective documentation of clinicopathological parameters, and serial measurements of infectious markers pre- and post-operatively. In-hospital complications are meticulously recorded, and long-term outcomes assessed through structured follow-up interviews at 3, 6, and 12 months. These follow-ups utilize standardized questionnaires to evaluate post-discharge infectious complications and gather patients' perspectives on their in-hospital experiences, providing a robust understanding of both clinical outcomes and patient-reported experiences.",[67,91,92,93,94,95,34,96],"Infections","Infection, Bacterial","Infection, Hospital","Infection Wound","Urinary Tract Infections","Urinary Tract Disease","2024-09-13",{"date":99,"type":45},"2024-09-19",{"date":101,"type":45},"2021-12-01",{"date":103,"type":21},"2025-12-31",{"name":105,"class":52},"Ludwig-Maximilians - University of Munich",1]