[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,78],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100635675","phase-1-calcium-electroporation-for-urinary-bladder-tumors-a-first-in-human-feasibility-safety-and-early-response-trial-100635675",false,"NCT07555769","Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial","Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial","CALCIFER","Inclusion Criteria:\n\n* Age ≥ 18 years and able to understand participant information and give informed consent\n* Histologically verified urothelial bladder tumor\n* Unfit for cystectomy and\u002For radiotherapy\n* Patients with recurrence after radiotherapy unfit for salvage cystectomy\n* Disease where other treatments are considered unsuitable or have been declined by the patient\n* The patient may receive simultaneous systemic treatment\n* Selected high-burden non-muscle-invasive bladder tumors after MDT assessment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n* Life expectancy of ≥ 3 months\n* Patients must be deemed able to tolerate general anesthesia\n* Sexually active participants in the reproductive age must use contraception. Accepted contraception includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization\n* Patients must stop treatment with anticoagulants before surgery in accordance with national guidelines\n* Plasma ionized Ca2+ must be within the normal upper limit. Correction is allowed\n* Hematology\n\n  * Thrombocytes ≥ 50 billion\u002FL\n  * International normalized ratio (INR) ≤ 1.5. Correction is allowed\n\nExclusion Criteria:\n\n* Pregnancy (confirmed by a blood sample) or lactation\n* Allergy to calcium gluconate or any of its excipients\n* Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible\n* Contraindications to treatment with calcium gluconate as described:\n\n  * Hypersensitivity to calcium gluconate or any of its excipients\n  * Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in patients with limited alternative therapies. The anticipated benefits and structured safety precautions justify the ethical conduct of the investigation.",[27,28,29,30],"Bladder Tumors","Bladder Tumor","Urothelial Carcinoma (UC)","Urothelial Carcinoma Bladder",[32,33,34,35,36],"calcium electroporation","electroporation","transurethral electroporation","bladder tumors","urothelial tumor","NOT_YET_RECRUITING","2026-04-21",{"date":40,"type":41},"2026-04-29","ACTUAL",{"date":43,"type":21},"2026-06",{"date":45,"type":21},"2030-04",{"name":47,"class":48},"Juan Luis Vásquez","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100573852","xpert-bladder-monitor-a-non-invasive-follow-up-tool-for-detecting-relapse-in-high-grade-or-high-risk-bladder-cancer-100573852","NCT06751667","Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer","LIBERO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf\n* NMIBC high grade or high risk (already subjected to or currently undergoing treatment with BCG).\n* No contraindications to surgery\n\nExclusion Criteria:\n\n* Inability or unwillingness of the participant or their legal representative to provide written informed consent\n* Absolute contraindications to surgery or cystoscopy\n* Patients who have previously participated in clinical protocols involving chemotherapy drugs or immunotherapy\n* Patients with multiple recurrent tumors eligible for cystectomy or Muscle-Invasive Bladder Cancer (MIBC)",{"count":57,"type":21},50,[59],"NA","Main objectives:\n\nQualitative and quantitative monitoring of recurrences in patients with a previous diagnosis of high-grade bladder cancer at high risk of persistence\u002Frecurrence.\n\nEndpoints: Presence or absence of mRNA in urine with a dichotomous result; concordance between Xpert BM and histopathological examination\n\nClinical relevance: reduces by half the number of (invasive) cystoscopies during follow-up. The non-invasive nature of the test could improve patient compliance with follow-up. Interventional study because it would reduce by half the number of cystoscopies during follow-up of bladder cancer which is considered the gold standard in the follow-up of this tumor. However, these markers are already CE validated and described in the European guidelines and for this reason the risk would be low.",[62,63,27,64,65],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder Cancer","Bladder Cancer Recurrence","Cystoscopy",[67,68],"Xpert Bladder Monitor","Gene Xpert","2024-12-20",{"date":71,"type":41},"2024-12-30",{"date":73,"type":21},"2025-01-01",{"date":75,"type":21},"2032-01-01",{"name":77,"class":48},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100444835","phase-2-pembrolizumab-monotherapy-following-tri-modality-treatment-for-selected-patients-with-muscle-invasive-bladder-cancer-100444835","NCT05072600","Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer","A Pilot Study of Pembrolizumab Monotherapy as Maintenance Therapy in MIBC Patients Who Received Bladder-Preserving Trimodally Therapy and Achieved CR","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n2. Based on AJCC 8th edition: stage cT2-4N0M0，Urothelial carcinoma \\>50% and\n\n   * Requires definitive local therapy\n   * Has received maximum TURBT followed by tri-modality therapy\n   * Achieved CR after tri-modality therapy, the acceptable duration of time between completion of TMT and assessment of CR was 28-90 days.\n3. Tumor was located at one side of bladder wall.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Have adequate organ function prior to the start of study intervention.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Patients judged not to be candidates for radical cystectomy; patients with pN+ or T4b disease are considered to have unresectable disease; Has any distant metastases.\n4. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.\n5. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n6. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n9. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n13. Has an active infection requiring systemic therapy.\n14. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n19. Has had an allogeneic tissue\u002Fsolid organ transplant.",{"count":86,"type":21},54,[88],"PHASE2","This is a Phase II, single-arm, study of pembrolizumab as maintenance therapy in muscle-invasive bladder cancer (MIBC) participants who have received maximum TURBT and tri-modality treatment (TMT) and achieved CR. All participants will receive pembrolizumab monotherapy per 21 days no longer than 17 cycles until disease progression or death.",[63,91,27,92,93],"Bladder Neoplasms","Urinary Bladder Cancer","Neoplasms, Bladder",[95,96,97,98],"bladder cancer","radiotherapy","Pembrolizumab","tri-modality therapy","RECRUITING","2021-12-18",{"date":102,"type":41},"2022-01-10",{"date":104,"type":41},"2021-12-07",{"date":106,"type":21},"2029-11-01",{"name":108,"class":48},"Peking University First Hospital",1]