[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-bladder-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,40,72,97,122,144,182,209,235,254,285],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100642553","phase-2-multi-omics-based-phase--trial-of-trastuzumab-rezetecan-plus-camrelizumab-for-perioperative-therapy-in-her2-positive-muscle-invasive-urothelial-carcinoma-100642553",false,"NCT07639983","Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma","Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined With Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics","Inclusion Criteria:\n\n1. Aged ≥18 years old with no restriction on gender.\n2. Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance.\n3. Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous\u002Fglandular differentiation is acceptable only when urothelial component dominates the lesion).\n4. Clinically or radiologically diagnosed muscle-invasive bladder cancer (MIBC): cT2-T4a, N0-1, M0 per AJCC\u002FUICC staging system; all imaging assessments shall be completed within 28 days prior to enrollment.\n5. HER2-positive tumor defined as IHC 1+, 2+ or 3+ tested on archival tumor specimen before enrollment via designated or central laboratory.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Candidates eligible for radical surgery: planned to receive radical cystectomy (RC), and investigators confirm feasibility of subsequent TURBT consistent with study protocol.\n8. Satisfactory major organ function to tolerate perioperative treatment:\n\n   * Hematology: ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL;\n   * Liver function: ALT\u002FAST ≤2.5×ULN, total bilirubin ≤1.5×ULN;\n   * Renal function: creatinine clearance ≥50 mL\u002Fmin calculated by Cockcroft-Gault or MDRD formula;\n   * Cardiac function: LVEF ≥50% detected by echocardiography without symptomatic heart failure (due to trastuzumab-related cardiac risk).\n9. Fertile subjects agree to use effective contraception throughout study period and for defined duration after last study drug administration.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator.\n2. Prior systemic anti-tumor therapy for current bladder cancer, including neoadjuvant\u002Fadjuvant\u002Fmetastatic chemotherapy, immunotherapy or anti-HER2 agents; previous exposure to PD-1\u002FPD-L1 inhibitors, anti-HER2 monoclonal antibodies or ADCs that may interfere with efficacy or safety evaluation per investigator's judgment.\n3. Previous pelvic radiotherapy, or unrecovered major surgery\u002Fsevere trauma within predefined time window before enrollment.\n4. Active autoimmune disease or patients requiring long-term systemic immunosuppressive therapy (daily prednisone\\>10 mg or equivalent dose; topical\u002Finhaled\u002Fshort-course steroid use is permitted).\n5. Uncontrolled active or severe bacterial infection, active tuberculosis; viral infection: HBsAg positive with elevated HBV DNA without standardized antiviral treatment, positive HCV RNA without disease control, or confirmed HIV infection per local institutional standard; clinically significant cardiovascular disorders including congestive heart failure, recent myocardial infarction, unstable angina, uncontrolled arrhythmia, baseline LVEF\\\u003C50%, or subjects inappropriate for trastuzumab administration judged by investigator.\n6. Previous or ongoing interstitial lung disease\u002Fnon-infectious pneumonitis, or obvious interstitial pulmonary changes on imaging with high risk of immune-related pneumonitis assessed by investigator.\n7. Known severe hypersensitivity to trastuzumab, camrelizumab or any excipients of investigational drugs; pregnant or breastfeeding females, or those planning pregnancy throughout study period.\n8. Severe psychiatric\u002Fcognitive disorder or substance abuse preventing regular follow-up and efficacy assessment.\n9. Any other conditions inappropriate for trial enrollment such as severe comorbidities or extremely short expected survival, as determined by the investigator.","ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological complete response (pCR) rates, and the achievement rate of tumor downstaging for bladder preservation; in addition, a subset of patients have limited tolerance or eligibility to chemotherapy. Therefore, this study aims to evaluate the neoadjuvant regimen of Ruikang Trastuzumab combined with Camrelizumab, to determine whether this regimen can, with acceptable safety profiles: elevate pCR rate and the proportion of patients downstaged to ≤T1 disease, enable bladder preservation based on TURBT for eligible patients, and explore predictive biomarkers to identify the population most likely to derive clinical benefits.",[26,27],"Muscle-Invasive Bladder Cancer (MIBC)","Urinary Bladder Cancer","NOT_YET_RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":20},"2026-06-05",{"date":36,"type":20},"2028-12-31",{"name":38,"class":39},"Sheng Tai","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100579262","phase-2-sequential-gemcitabine-and-mitomycin-treatment-for-favorable-high-risk-upper-urinary-tract-urothelial-carcinoma-100579262","NCT06822010","SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma","A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)","Inclusion Criteria:\n\n* Subjects must meet all of the following applicable inclusion criteria to participate in the study:\n\n  1. Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.\n  2. Patient is at least 18 years of age.\n  3. Naive or recurrent patients with High Grade Ta +\u002F- CIS, non-invasive UTUC in the upper tract (pyelocalyceal system or ureter).\n* Histologic confirmation with biopsy is necessary.\n* All patients must undergo ureteroscopy with biopsy.\n* Non-Invasive Papillary Carcinoma (HGTa) lesions must be maximally ablated with ≤ 15 mm residual papillary disease in total.\n\n  4\\. Favorable high-grade upper tract urothelial carcinoma (UTUC) as per American Urological Association (AUA) risk stratification below (except that multifocality, obstruction, ureteral involvement, bladder involvement will be allowed).\n  1. If the bladder is involved with NMIBC it should be treated prior to or during Gem\u002FJel treatments.\n\n     5\\. Patients with ECOG (Eastern Cooperative Oncology Group) performance status \\\u003C3 (with Karnofsky \\>40).\n\n     6\\. Patients with life expectancy greater than 24 months at time of screening. 7. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis\\*.\n\n     8\\. Female Patients of childbearing potential\\*\\*, must have a negative serum pregnancy test at screening and must agree to use two acceptable \\& effective methods of contraception\\*\\*\\*, until 6 months post treatment 9. All sexually active male patients must agree to use a condom during intercourse, for at least 48 hours post each instillation.\n\n     10\\. Male patients who have a partner that is a female of childbearing potential must agree to use two acceptable \\& effective methods of contraception until 6 months post treatment.\n\n     11\\. Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the investigator.\n\n     Exclusion Criteria:\n\n     Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.\n\n     4\\. Any other malignancy diagnosed within 2 years of trial entry with the exception of:\n\n  a. Basal or squamous cell skin cancers, or b. Noninvasive cancer of the cervix, or c. Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period (basal or squamous cell skin cancers, noninvasive cancer of the cervix, prostate cancer under active surveillance, renal cancer under active surveillance).\n\n  4\\. Administration not feasible via nephrostomy tube. 5. Inability to deliver the investigational drug to the pyelocalyceal system. 6. Patient has any other medical or mental condition(s) that make(s) his\u002Fher participation in the trial unadvisable in the opinion of the treating urologist.\n\n  7\\. Patient has contraindication to mitomycin C (MMC )treatment, or known sensitivity to MMC.\n\n  8\\. Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease).\n\n  9\\. Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 30 days prior to Visit 1.\n\n  10\\. Pregnant (positive serum pregnancy test), planning to become pregnant during the trial period, breast-feeding, or of childbearing potential and not practicing reliable contraception\\*\\*\\*.\n\n  \\* In case of a symptomatic UTI the patient will be treated with a full course of antibiotics, and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of the treatment is left to the discretion of the PI.\n\n  \\*\\* Women of non-childbearing potential:\n  1. At least 12 months since the last menses, or\n  2. Without uterus and\u002For both ovaries, or\n  3. Has been surgically sterile for at least 6 months prior to trial drug administration.\n\n     * Acceptable methods of birth control which are considered to have a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen\u002Fprogesterone) oral contraceptives, intrauterine devices (IUDs-only hormonal), condoms with spermicide, sexual abstinence or vasectomized partner.","99 Years",{"count":49,"type":20},28,[23],"This Phase II clinical trial, titled \"A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT),\" aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.",[27,53,54],"Upper Tract Urothelial Cancer","Urothelial Cancer",[56,57,58,59,60],"upper tract urothelial cancer","urothelial cancer","gemcitabine","jelmyto","mitomycin","RECRUITING","2026-05-02",{"date":64,"type":32},"2026-05-06",{"date":66,"type":32},"2026-03-06",{"date":68,"type":20},"2029-04-01",{"name":70,"class":39},"Rutgers, The State University of New Jersey",1,{"id":73,"slug":4,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":71},"100488740","NCT05644041","Intravesical Gem\u002FDoce in Patients With NMIBC","Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy","Inclusion Criteria:\n\n1. Patients able to consent in English or Spanish; provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female ages ≥18 years.\n4. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.\n\n   1. Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.\n\n6\\. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2. 7. Post-transurethral bladder tumor resection. 8. Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to gemcitabine and\u002For docetaxel.\n2. Clinical T2 or higher stage UC of the bladder.\n3. Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.\n4. Active malignancies other than the disease being treated under study.\n5. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.\n6. Pregnant or breast-feeding women.\n7. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.",{"count":79,"type":20},25,[23],"Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem\u002FDoce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.",[27],[84,85,86,87],"Bacillus Calmette-Guérin (BCG)","Nonmuscle invasive bladder cancer (NMIBC)","Intravesical immunotherapy","Post-transurethral resection","2026-02-25",{"date":90,"type":32},"2026-02-27",{"date":92,"type":32},"2023-03-01",{"date":94,"type":20},"2027-01-31",{"name":96,"class":39},"University of Arizona",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":71},"100123330","evaluation-of-non-invasive-assays-for-the-detection-of-urothelial-cancer-100123330","NCT00872495","Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer","Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney","Inclusion Criteria:\n\n* Patients scheduled to have a nephroureterectomy, cystectomy, cytoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up)\n* Control Group: No known evidence of bladder cancer-one urine sample\n* \\> than 18 years of age\n\nExclusion Criteria:\n\n* \\\u003C than 18 years of age",true,{"count":106,"type":20},500,"OBSERVATIONAL","The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of urothelial cancer of the bladder and kidney. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence",[54,110,111,27],"Cancer","Bladder Neoplasms",[54,110,111,27],"2025-12-01",{"date":115,"type":32},"2025-12-08",{"date":117,"type":4},"2002-09",{"date":119,"type":20},"2028-11",{"name":121,"class":39},"Lahey Clinic",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":71},"100607089","phase-2-neoadjuvent-dose-dense-gemcitabine-and-cisplatin-in-muscle-invasive-bladder-cancer-100607089","NCT07184021","Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer","Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer:Results of a Phase 2 Trial","No Acronym","Inclusion Criteria:\n\n* Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0.\n* Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL\u002Fmin).\n* Candidate for radical cystectomy after neoadjuvant treatment.\n* ECOG performance status 0-1.\n* Adequate bone marrow, liver, and renal function as per institutional standards.\n\nExclusion Criteria:\n\nHistology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%).\n\n* Clinical or radiological evidence of distant metastases (M1).\n* Prior systemic chemotherapy or radiotherapy for bladder cancer.\n* Significant renal impairm ent (creatinine clearance \\\u003C 60 mL\u002Fmin).\n* ECOG performance status ≥ 2.\n* Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).",{"count":131,"type":20},30,[23],"To evaluate the feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy.",[27],"2025-09-13",{"date":137,"type":32},"2025-09-19",{"date":139,"type":20},"2025-09",{"date":141,"type":20},"2027-09",{"name":143,"class":39},"Assiut University",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":154,"conditions":155,"keywords":166,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":71},"100605647","association-of-pocd-with-circulating-biomarkers-in-patients-undergoing-tur-of-bladder-tumor-100605647","NCT07165236","Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor","Association of Perioperative Cognitive Dysfunction With Circulating Biomarkers of Neurological Damage in Patients Underging Transurethral Resection of Bladder Tumor","Inclusion Criteria:\n\n* adult patients from 18-80 years,\n* elective operations of tumor bladder cancer (TUR),\n* patients can communicate,\n* patients who can sign the information consent and questionnaires\n\nExclusion Criteria:\n\n* patients under the age of 18,\n* patients above 80 years,\n* patients who are unable to communicate\n* patients who do not understand informed consent for the research,\n* patients who are unable to write\n* emergency surgery,\n* patients with proven hypersensitivity to some of the drugs used in the study\n* patients in a state of shock, septic, or hemorrhagic patients with neurodevelopmental disorders","80 Years",{"count":153,"type":20},42,"Bladder tumor is one of the most widespread tumors in the world, with increasing prevalence at the global level. One of the procedures in patients with bladder tumors is transurethral resection of the bladder (TURM) most often performed endoscopically under general anesthesia. This patient population has certain characteristics in common. One of them is exposure to common risk factors for the formation of bladder tumors, such as aniline dyes and solvents. These substances are associated with the onset of neurodegeneration and oxidative stress. Smoking is another factor that affects the formation of bladder tumor. A significant part of patients with bladder tumor are an elderly population, which is repeatedly exposed to surgical procedures, with numerous comorbidities, with a high risk of postoperative complications and the development of perioperative cognitive deficits, which can further complicate the postoperative course and further treatment. In the group of patients with a bladder tumor who will undergo TURM, no evaluation of risk factors related to perioperative cognitive deficit was performed, nor was there an examination of the perioperative cognitive deficit itself. In them, the identification of factors for postoperative cognitive disorder is essential. The concept of clinical frailty is becoming more important and relevant when providing healthcare services to patients. The use of the clinical frailty scale as a tool in clinical practice provides information on the adequate direction of care for patients. Decrease in muscle strength can lead to limitations in the functioning of a certain individuals. In recent years muscle strength has come to be a very important component of health, regardless of a person's age and clinical condition.The hand grip test is a test used to measure the maximum isometric strength of the hand and forearm muscles. The MMSE test and MoCA are the most frequently used methods in the detection of cognitive impairment in clinical and research fields. In addition to laboratory indicators of organic function, circulating indicators of neuroinflammation, like S100B and neuron-specific enolase, will be correlated with the patient's cognitive status.So far, no research has been conducted on the dynamics of indicators of organic function, circulating indicators of neuroinflammation, perioperative cognitive changes and clinical fraility in patients undergoing bladder tumor operation.",[156,27,157,158,159,160,161,162,163,164,165],"Cognitive Decline","Frail","Biomarker","General Anesthesia","Hand Grip Strength","Cognitive Testing","Comorbidities","Demographic Data","Socio-economic Status","Perioperative Complications",[167,168,169,170,171,172],"general anesthesia","postoperative cognitive complications","urinary bladder neoplasm","perioperative period","frail older adult","S100b","2025-09-02",{"date":175,"type":32},"2025-09-10",{"date":177,"type":32},"2024-11-28",{"date":179,"type":20},"2029-10-01",{"name":181,"class":39},"Osijek University Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":71},"100487035","quantifying-systemic-immunosuppression-to-personalize-cancer-therapy-100487035","NCT05621837","Quantifying Systemic Immunosuppression to Personalize Cancer Therapy","Serpentine","Inclusion Criteria\n\n* Histologically documented diagnosis of metastatic\u002Flocally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included\n* Will and ability to comply with the protocol\n* Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis\n* Age from 18 to 90 years at the time of recruitment\n* ECOG Performance Status \\\u003C= 2\n* Understanding and signature of the informed consent\n* Consenting to participate to the socio-economical-psychological survey\n\nExclusion Criteria\n\n* Known history of HIV infection\n* Serious neurological or psychiatric disorders\n* Pregnancy or lactation\n* Inability or unwillingness of participant to give written informed consent\n* Inability or unwillingness to be regularly followed up at the same center","90 Years",{"count":191,"type":20},1000,"The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.",[194,195,196,27,197,198,199],"Melanoma","Breast Cancer","Renal Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Small Cell Carcinoma","NSCLC","2025-04-29",{"date":202,"type":32},"2025-05-02",{"date":204,"type":32},"2022-03-10",{"date":206,"type":20},"2026-12-31",{"name":208,"class":39},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":71},"100428632","phase-2-neoadjuvant-toripalimab-in-combination-with-gemcitabine-and-cisplatin-therapy-in-local-advanced-bladder-cancer-subjects-100428632","NCT04861584","Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects","Phase II Study of Neoadjuvant Toripalimab with Gemcitabine-Cisplatin in Subjects with T2-4aN0M0 Bladder Cancer: GZZJU-2021NB","Inclusion Criteria:\n\n* Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;\n* ECOG score 0-1 points, expected survival time\\> 6 months;\n* Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition);\n* Appropriate and plan for radical cystectomy;\n* According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm);\n* Since the diagnosis of locally advanced bladder urothelial carcinoma, patient has not received anti-tumor system treatment;\n* The main organ functions are normal, and the following requirements must be met within 2 weeks before the first study treatment:\n* Routine blood examination must meet: WBC≥4.0×109\u002FL; PLT≥90×109\u002FL; Hb≥90g\u002FL (patients can be infused with red blood cells to meet this standard);\n* Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL\u002Fmin; TBIL≤1.5×ULN; ALB≥30g\u002FL; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN.\n* Female patients with fertility must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration;\n* Agree to provide diagnosis and treatment-related tumor tissue specimens for clinical research, and have the ability to follow the planned research visit until the clinical recurrence\u002Fprogress is clear.\n* Sign informed consent voluntarily.\n\nExclusion Criteria:\n\n* Have previously received anti-PD1\u002FPDL1\u002FCTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;\n* Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;\n* Have received radiotherapy of the bladder in the past;\n* Patients with any history of active autoimmune disease or autoimmune disease;\n* Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids. It is forbidden to use prednisone greater than 10 mg\u002Fday or the same dose in the 2 weeks before the use of the study drug;\n* Combined with other malignant tumors;\n* Have a history of allergy to other antibody drugs;\n* The history of human immunodeficiency virus (HIV) infection;\n* The subject has active infection, including active tuberculosis;\n* Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;\n* Kidney transplant patients;","75 Years",{"count":218,"type":20},41,[23],"This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.",[27],[223,224,225],"bladder cancer","checkpoint inhibitor","neoadjuvant therapy","2024-11-30",{"date":228,"type":32},"2024-12-04",{"date":230,"type":32},"2021-06-03",{"date":232,"type":20},"2027-04-03",{"name":234,"class":39},"Zhujiang Hospital",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":241,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":4},"100568011","predictive-role-of-microbiome-in-patients-with-urothelial-carcinoma-100568011","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.",{"count":242,"type":20},420,"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.",[27],"2024-11-04",{"date":247,"type":32},"2024-11-05",{"date":249,"type":20},"2024-11",{"date":251,"type":20},"2035-11",{"name":253,"class":39},"IRCCS San Raffaele",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100350549","phase-1-a-study-of-mitomycin-c-capecitabine-chemoradiotherapy-combined-with-nivolumab-monotherapy-or-ipilumimab-and-nivolumab-as-bladder-sparing-curative-treatment-for-muscle-invasive-bladder-cancer-the-crimi-study-100350549","NCT03844256","A Study of Mitomycin-c\u002F Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study","A Phase 1b-2 Study of Mitomycin-c\u002F Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study","CRIMI","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial.\n* Be ≥ 18 years of age on day of signing informed consent.\n* Wish to preserve their bladder function or be ineligible for cystectomy.\n* Must have undergone transurethral biopsy of the bladder tumor, within 35 days of planned treatment commencement. The patient should have a histologically-confirmed diagnosis of muscle-invasive T2-T4a, N0-1M0 urothelial cell carcinoma of the bladder.\n* Must have undergone maximal transurethral resection of the bladder tumour, to an extent that is judged as safe by the urologist performing the resection, within 35 days of planned treatment commencement.\n* Subjects with tumors of mixed urothelial\u002Fnon-urothelial cell histology are allowed, but urothelial cell carcinoma must be the predominant histology (\\>50%). Subjects with predominant or exclusively non-urothelial cell histology are not allowed.\n* Have planned for chemoradiotherapy as definitive treatment.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale\n* Have a bladder function that is accessible for cystoscopical follow up.\n* Demonstrate adequate organ function. All screening labs should be performed within 28 days of registering the patient on the trial.\n* Female participants of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female participants of childbearing potential should be willing to one highly effective method of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 month after the last dose of study medication Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n* Male participants should agree to use condoms starting with the first dose of study therapy through 7 month after the last dose of study therapy.\n* Willing to consent to the use of their collected tumor specimen, blood and urine as detailed in the protocol for future scientific research including but not limited to DNA, RNA and protein based biomarker detection.\n\nExclusion Criteria:\n\n* Has DPD deficiency.\n* Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) urothelial cell carcinoma of the urothelium. Patients who have involvement of the prostatic urethra with urothelial cell cancer may be included if the location can be safely incorporated in the radiation field.\n* Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative chemoradiotherapy.\n* Evidence of distant metastatic disease on a CT or FDG PET\u002FCT chest\u002Fabdomen\u002Fpelvis performed within 28 days prior to study entry. Up to 3 metastatic lymphnodes in the pelvis (below the common iliac arteries) are allowed, if these can be incorporated in the radiotherapy field.\n* Prior pelvic lymph-adenectomy\n* Prior pelvic radiotherapy\n* Has had prior intravenous chemotherapy, targeted small molecule therapy, or radiation therapy for treatment of bladder cancer. Prior intravesical use of BCG and MMC is permissible.\n* Unsuitable for concurrent MMC \u002F capecitabine based ChRT based on pre-existing medical conditions.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy over 10mg daily prednisone (or equivalent) or any other form of immunosuppressive therapy within 14 days prior to registering the patient. Patients with adrenal insufficiency receiving replacement dose steroids are allowed on the trial.\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Hypersensitivity to nivolumab and\u002For ipilimumab or any of its excipients.\n* Prior or concurrent known additional malignancy of any site unless disease free for 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, Stage T1a well differentiated prostatic carcinoma in men (Gleason = 3+3, PSA \\\u003C5)\n* Has any history of active autoimmune disease, Stevens-Johnson syndrome or Guillain-Barre. Exceptions to this are:\n\n  1. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone\n  2. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n* Has an Human Immunodeficiency Virus (HIV) infection with a PCR detectable viral load.\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.",{"count":263,"type":20},50,[265,23],"PHASE1","A multicenter Phase 1b\u002F2, two stage, open label study of MMC\u002FCapecitabine ChRT combined with nivolumab monotherapy or nivolumab and ipilimumab combination therapy in adult (\\>18 years) subjects with non-metastatic muscle invasive bladder cancer that qualify for ChRT with curative intent.",[27,268],"Invasive Bladder Cancer",[270,271,272,273,274],"Immunotherapy","Chemoradiotherapy","Nivolumab","Ipilimumab","bladder sparing treatment","2022-08-11",{"date":277,"type":32},"2022-08-12",{"date":279,"type":32},"2019-01-07",{"date":281,"type":20},"2026-07",{"name":283,"class":39},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",3,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":21,"phases":294,"briefSummary":295,"conditions":296,"keywords":300,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":71},"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":293,"type":20},54,[23],"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.",[297,111,298,27,299],"Bladder Cancer","Bladder Tumors","Neoplasms, Bladder",[223,301,302,303],"radiotherapy","Pembrolizumab","tri-modality therapy","2021-12-18",{"date":306,"type":32},"2022-01-10",{"date":308,"type":32},"2021-12-07",{"date":310,"type":20},"2029-11-01",{"name":312,"class":39},"Peking University First Hospital"]