[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"utuc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:utuc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,79,104,127],{"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":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100640859","non-invasive-urinary-genomics-based-risk-assessment-for-early-urothelial-carcinoma-diagnosis-100640859",false,"NCT07614594","Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis","Non-invasive Urinary Genomics-Based Risk Assessment for Early Diagnosis of Urothelial Carcinoma","Inclusion Criteria:\n\nPatients are eligible if they meet all of the following criteria:\n\n1. Age ≥ 18 years.\n2. Presence of gross or microscopic hematuria.\n3. Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion.\n4. Scheduled for surgery for tissue histopathological diagnosis.\n5. Able to provide written informed consent.\n\nExclusion Criteria\n\n1. Inadequate urine sample (poor quality or insufficient volume).\n2. Lack of final histopathological diagnosis.","ALL","18 Years",{"count":19,"type":20},800,"ESTIMATED","OBSERVATIONAL","This is a two-stage, prospective, single-center observational diagnostic accuracy study evaluating noninvasive urine testing for the detection of urothelial carcinoma (UC). The study enrolls adult patients presenting with gross or microscopic hematuria and imaging evidence of a space-occupying lesion in the renal pelvis, ureter, or bladder, who are scheduled for diagnostic cystoscopy and\u002For surgical tissue sampling. Histopathological examination serves as the reference standard.\n\nStage 1 (Completed, 8th October 2019 - 31st December 2023):\n\nA total of 113 participants have been enrolled. Owing to sufficient research funding, all participants in this stage underwent four urine-based tests: cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel.\n\nStage 2 (Ongoing, from 1st January 2024):\n\nThe testing protocol was refined to focus on urine DNA methylation alone, owing to limited research funding and the lower cost of DNA methylation compared with the 17-gene mutation panel. As of registration (May 2026), approximately 330 participants have been enrolled.\n\nAll enrolled participants are categorized into two groups based on histopathology: a UC group (including upper tract urothelial carcinoma \\[UTUC\\] and bladder cancer \\[BC\\]) and a non-UC control group. The primary outcome is the diagnostic accuracy (area under the receiver operating characteristic curve \\[AUC\\] with 95% confidence interval, sensitivity, and specificity) of the four urine-based tests in the Stage 1 cohort. The key secondary outcome is the diagnostic accuracy of urine DNA methylation in the Stage 2 cohort. Other secondary outcomes include paired comparisons of AUCs among the four tests in the Stage 1 cohort. Exploratory analyses will include the diagnostic performance of urine cytology in a subset of Stage 2 participants with UTUC, as well as subgroup analyses by tumor site (UTUC vs. BC).\n\nBecause this study is purely observational and non-interventional, prospective registration was not a regulatory or institutional requirement when enrollment began in 2019. This record is being submitted prior to any data analysis to ensure consistency with current research transparency standards.",[24,25,26,27],"Urothelial Carcinoma (UC)","Upper Tract Urothelial Carcinoma","UTUC","Bladder Cancer (BC)",[29,30,31,32,33,34,35,36,37,38,39],"urothelial carcinoma","upper tract urothelial carcinoma","DNA methylation","17 genes mutation","diagnosis","bladder cancer","diagnostic efficacy","urine sample","cytology","fluorescence in situ hybridization","non-invasive detection","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2019-10-08",{"date":48,"type":20},"2030-12-31",{"name":50,"class":51},"Henan Provincial People's Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":52},"100592318","a-multicenter-prospective-cohort-study-on-monitoring-recurrence-of-urothelial-carcinoma-based-on-detection-of-urinary-microscopic-residual-disease-mrd-100592318","NCT06991868","A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD)","Cohort I:\n\nInclusion Criteria:\n\n* patients ≥18 years of age with full civil capacity at the time of signing the informed consent form;\n* patients who provide a urine sample for MRD testing at the time of undergoing postoperative review;\n* Pathologic type: required to be a pathologically confirmed uroepithelial tumor with a predominantly urothelial tumor with a primary site in the upper urinary tract (including the renal pelvis and ureters), and permitted to contain no more than 50% squamous differentiation, adenomatous differentiation, or sarcomatoid differentiation and are pT3\u002F4 or any TpN+.\n\nExclusion Criteria:\n\n* Pathology after radical surgery that does not meet the criteria for enrollment;\n* Predictable inability to meet the criteria for regular review at our center within 1 year postoperatively;\n* Disagreement with regular cystoscopy and\u002For imaging (at least completion of one of CT or MR or PET\u002FCT, with intervals between reviews as well as the specific items to be determined by the clinician);\n* Already definite recurrence or metastasis;\n* Concomitant combination of other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)\n\nCohort II:\n\nInclusion Criteria:\n\n* patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;\n* patients who provided a urine sample for central testing when they underwent postoperative review;\n* Pathological type: a pathologically confirmed predominantly uroepithelial tumor with a primary site in the bladder is required, and is permitted to contain no more than 50% squamous differentiation, or adenoidal differentiation carcinoma in situ is permitted to be present or only in situ and the pathologic stage may be T1, Ta, or Tis (Cis)\n\nExclusion Criteria:\n\n* TUR pathology that does not meet the enrollment criteria;\n* predictable inability to meet the regular review at our center within 1 year postoperatively;\n* disagreement with regular cystoscopy and\u002For imaging (the content and type of imaging will be determined by the clinician);\n* definite recurrence or metastasis already exists;\n* concurrent combination of other active malignant neoplastic disease or a 5-year history of other malignant neoplastic disease history (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment)\n\nCohort III:\n\nInclusion Criteria:\n\n* patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;\n* patients providing urine samples for centralized testing prior to each cycle of treatment during neoadjuvant therapy;\n* pathology type: a predominantly uroepithelial tumor with a TUR surgical pathology primary site in the bladder is required, and is permitted to contain no more than 50% squamous, adenomatous, or sarcomatoid differentiation (iii) Patients with pathologic stage T2 or MIBC on comprehensive imaging despite pathologic stage T1;\n* Radical cystectomy after neoadjuvant therapy, including bladder, prostate, and seminal vesicles in men and bladder and uterus in women;\n* lymph node dissection at least to the extent of the standard dissection for bladder cancer (including the area of the common iliac arteries below the bifurcation of the iliac arteries bilaterally and the area between the ipsoas and genitofemoral nerve to the ureter);\n* the presence of evaluable lesions on imaging based on RECIST 1.1 criteria prior to neoadjuvant therapy.\n\nExclusion Criteria:\n\n* TUR pathology that does not meet enrollment criteria;\n* does not undergo radical total cystectomy or standard surgical scope;\n* receives less than 2 cycles of neoadjuvant therapy;\n* does not undergo regular imaging evaluations during preoperative neoadjuvant therapy;\n* has no evaluable lesions prior to neoadjuvant therapy;\n* already has definitively present distant metastases;\n* concurrently combines other active malignant neoplastic disease or a history of other malignant neoplastic disease within 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).\n\nCohort IV:\n\nInclusion Criteria:\n\n* patients aged ≥18 years at the time of signing the informed consent form with full civil capacity;\n* patients to provide a urine sample for centralized testing at each review visit;\n* pathology type: the TUR surgical pathology is required to be a predominantly urothelial tumor with a primary site in the bladder, and is allowed to contain no more than 50% squamous, adenomatous, or sarcomatous differentiation;\n* there should be a centralized imaging to assess a clinical assessment of MIBC prior to TMT treatment;\n* patients assessed as clinically CR after undergoing TMT who can continue to retain their bladder and do not require salvage cystotomy.\n\nExclusion Criteria:\n\n* TUR pathology that does not meet the inclusion criteria;\n* predictable inability to meet the regular review at our center within 1 year after surgery;\n* no pre-treatment imaging at our center;\n* disagreement with regularity of receiving imaging (the clinician decides on the content and type of imaging);\n* residual lesions or metastases that are already clearly present;\n* concurrent combination of other active malignant neoplastic diseases or a history of other malignant neoplastic diseases within 5 year history of other malignant neoplastic disease (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment).","18 Months",{"count":61,"type":20},300,"This was a multicenter, prospective, non-interventional, observational cohort study, and the enrolled patients were divided into four cohorts: cohort I was patients with high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+); cohort II was patients with non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk\u002Fvery-high-risk); cohort III was patients with muscle-invasive bladder cancer (MIBC) to receive neoadjuvant therapy; and cohort IV was patients evaluated for complete response (CR) after standard trimodality therapy (TMT) treatment (i.e. patients with successful bladder preservation). Primary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence\u002Fmetastasis; Cohort II: MRD score to assess the sensitivity and specificity of tumor recurrence; Cohort III: MRD score to assess the sensitivity and specificity of tumor remnants. Secondary Objectives Cohorts I and IV: MRD score to assess the sensitivity and specificity of imaging recurrence subgroup and metastasis subgroup; Cohort II: MRD score to assess the sensitivity and specificity of different grades and stages of recurrent tumors; Cohort III: MRD scores to assess the sensitivity and specificity of different grades and stages of residual tumors.",[64,65,26],"NMIBC","MIBC",[67,68,69],"high-risk upper tract urothelial carcinoma (UTUC) (pT3-4 or N+)","non-muscle invasive bladder cancer (NMIBC) (including low-risk, intermediate-risk, and high-risk\u002Fvery-high-risk)","muscle-invasive bladder cancer (MIBC)","2025-05-27",{"date":72,"type":44},"2025-05-28",{"date":74,"type":44},"2024-03-01",{"date":76,"type":20},"2026-05-31",{"name":78,"class":51},"Peking University First Hospital",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":52},"100587341","phase-2-neoadjuvant-chemotherapy-in-high---risk-upper-tract-urothelial-carcinoma-100587341","NCT06927128","Neoadjuvant Chemotherapy in High - Risk Upper Tract Urothelial Carcinoma","Single - Center Phase II Clinical Study: Efficacy Evaluation of Neoadjuvant Chemotherapy With Gemcitabine and Cisplatin in High - Risk Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* Histologically confirmed high - risk upper tract urothelial carcinoma (UTUC). For mixed - type tumors, the histological type should be mainly urothelial carcinoma (≥50%), or urine cytology is positive and imaging diagnosis supports UC.\n* Clinically non - metastatic urothelial carcinoma (N≤1 M0), determined by imaging examinations (CT or MRI) of the chest\u002Fabdomen\u002Fpelvis.\n* Patients must plan to undergo radical nephroureterectomy (RNU).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Patients are potential beneficiaries of cisplatin - based neoadjuvant chemotherapy, with relatively good renal function (GFR≥45ml\u002Fmin) and able to tolerate drug treatment and surgery.\n* Sufficient organ and bone marrow function determined by screening tests.\n* Recovered from any reversible toxicity of previous surgery.\n* At least 18 years old on the date of registration.\n* Informed of the study nature and signed the informed consent form.\n\nExclusion Criteria:\n\n* Imaging - identified ≥N2 disease or metastatic disease (M1).\n* History of invasive or lymph node - positive or metastatic urothelial carcinoma or invasive contralateral upper tract carcinoma within 2 years before registration.\n* Patients with only one kidney, or cisplatin intolerant patients.\n* Participating in other interventional clinical trials at the time of registration.\n* History of non - urothelial malignancies, except those who have been disease - free for at least 1 year as judged by the treating oncologist. History of adequately treated (at the discretion of the treating oncologist) basal cell or squamous cell skin cancer or in - situ cervical cancer is allowed.\n* Pregnant or lactating women. Reproductive - potential women\u002Fmen must agree to use effective contraception methods.\n* Any other medical conditions that make the treating doctor consider their participation in the study inappropriate.\n\nWithdrawal\u002FTermination Criteria\n\n* Investigator - determined Withdrawal:\n* Tumor recurrence or progression during the clinical trial, and the investigator determines that the subject needs new treatment (such as immediate tumor resection or systemic anti - tumor treatment) and is not suitable to continue the trial. If the investigator judges that the subject can still receive treatment or follow - up for efficacy after tumor recurrence, the subject may not be withdrawn for the time being.\n* The subject develops comorbidities, complications, or special physiological changes that are not suitable for continuing the trial.\n* Poor compliance of the subject affecting safety and efficacy evaluation:\n* The subject does not take medicine or undergo examinations as required.\n* The subject uses other drugs or foods that affect safety evaluation.\n* The subject has other behaviors that affect the test results.\n* Unbearable toxicity, other adverse events, or serious adverse events occur, and the subject is not suitable to continue the trial.\n* A grade 3 adverse event related to the study drug occurs and persists for more than 12 days after taking sufficient treatment measures.\n* Systemic metastasis or progression is detected during the drug - administration observation period or the surgical period.\n* Subject - initiated Withdrawal: Subjects have the right to withdraw from the trial midway according to the informed consent form. If the subject does not withdraw the informed consent but no longer accepts trial drug administration and examinations or is lost to follow - up, it is also regarded as withdrawal. All withdrawn subjects should try to complete the corresponding observation content of the last visit as specified in the protocol. The reason for termination should be noted in the original document. If the subject withdraws due to an adverse event, appropriate treatment should be provided and recorded in the original record.",{"count":87,"type":20},45,"INTERVENTIONAL",[90],"PHASE2","Upper urinary tract urothelial carcinoma (UTUC) represents a rare yet aggressive malignancy associated with a dismal prognosis. At the point of diagnosis, nearly half of the patients already have invasive disease, and over 70% present with high-grade UTUC. Currently, radical nephroureterectomy (RNU) remains the gold standard of care for high-risk UTUC.\n\nPrevious investigations have demonstrated that, in contrast to RNU alone, chemotherapy can effectively reduce the disease recurrence rate and mortality. Moreover, it may confer benefits to patients' overall survival (OS) without impeding the implementation of subsequent definitive surgical treatment. However, the majority of these studies are predominantly retrospective analyses. Although they can, to some degree, reflect the clinical value of neoadjuvant chemotherapy, due to inherent limitations in study design and other confounding factors, there is still a paucity of prospective research evidence for further validation.\n\nConsidering that RNU can cause a decline in renal function in patients, and in light of prospective trial outcomes, preoperative neoadjuvant chemotherapy (NAC) has emerged as a preferred treatment option for chemotherapy-eligible UTUC patients.",[26,93],"NAC","NOT_YET_RECRUITING","2025-04-13",{"date":97,"type":44},"2025-04-15",{"date":99,"type":20},"2025-05-15",{"date":101,"type":20},"2028-06-15",{"name":103,"class":51},"Changhai Hospital",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":88,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":52},"100509724","phase-2-a-study-of-rc48-adc-combined-with-js001-for-postoperative-adjuvant-treatment-of-upper-tract-urothelial-carcinoma-100509724","NCT05917158","A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma","An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)","1","Inclusion Criteria:\n\n* Written informed consent\n* ≥18 years of age\n* Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC\u002FSCC is permitted.\n* Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).\n* Pathological tissue immunohistochemistry HER2 2\\~3+\n* Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated\n* ECOG(Eastern Cooperative Oncology Group) performance is 0\\~2.\n* Available for long-term follow-up\n\nExclusion Criteria:\n\n* Evidence of distant metastases\n* Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology\n* Un-resected macroscopic nodal disease\n* Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)\n* Significant co-morbid conditions that would interfere with administration of protocol treatment\n* Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);\n* Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.",{"count":113,"type":20},30,[90],"This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.",[117,25,26],"Carcinoma","2025-01-20",{"date":120,"type":44},"2025-01-22",{"date":122,"type":44},"2022-11-23",{"date":124,"type":20},"2028-12",{"name":126,"class":51},"Jinling Hospital, China",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":88,"phases":136,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100528921","post-urs-chemotherapy-instillation-100528921","NCT06167057","POST URS Chemotherapy Instillation","Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence","Inclusion Criteria:\n\n* Radiographic and\u002For cytological suspicion for UTUC\n* Planned endoscopic procedure for treatment \u002F diagnosis of UTUC\n* Patients with bladder cancer history are eligible if meeting both following criteria:\n\nNo recurrence within the last two years Are not on active bladder irrigation protocol\n\n* Patients with history of UTUC are eligible if last endoscopic treatment or RNU was \\>1 year prior to enrollment\n* Age ≥ 18 years\n* Performance status ECOG 0-2\n\nExclusion Criteria:\n\n* Subjects who have had bladder \u002F prostate radiotherapy\n* Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment\n* Subjects with previously treated UTUC within one year prior to enrollment\n* Subjects with metastatic disease",{"count":135,"type":20},264,[137],"NA","The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR.\n\nParticipants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.",[26],[141,142,143],"diagnostic URS","single-dose chemotherapy bladder instillation","IVR","2023-12-14",{"date":146,"type":44},"2023-12-20",{"date":148,"type":44},"2023-04-17",{"date":150,"type":20},"2028-01-30",{"name":152,"class":51},"Carmel Medical Center",10]