[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03193541":3,"trial-entities:NCT03193541":166,"trial-summary:NCT03193541":170},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":31,"sex":34,"minimum_age":35,"maximum_age":36,"healthy_volunteers":21,"eligibility_criteria":37,"std_ages":51,"locations":54,"central_contacts":144,"overall_officials":149,"references":154,"see_also_links":165},"NCT03193541","Rosser-2015-8","A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer","RECRUITING","2029-02","2026-02","2026-02-04","2016-12-30","Cedars-Sinai Medical Center","OTHER",true,"To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.","Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.\n\nWe propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.",[18],"Bladder Cancer",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},900,"ESTIMATED",[],[28],{"measure":29,"timeFrame":30},"Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.","1 year",[32],{"measure":33,"timeFrame":30},"Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.","ALL","18 Years","90 Years",{"inclusion":38,"exclusion":42,"raw_text":50},[39,40,41],"Age 18 years or older","Have documented or reported microscopic hematuria within 3 month of study enrollment","Willing and able to give written informed consent",[43,44,45,46,47,48,49],"Have history of BCa","History of previous cancer (excluding basal and squamous cell skin cancer)","Have a known active urinary tract infection or urinary retention","Have active stone disease (renal or bladder) or renal insufficiency (creatinine \\>2.0 mg\u002FdL)","Have ureteral stents, nephrostomy tubes or bowel interposition","Have recent genitourinary instrumentation (within 10 days prior to signing consent)","Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)","Inclusion Criteria:\n\n* Age 18 years or older\n* Have documented or reported microscopic hematuria within 3 month of study enrollment\n* Willing and able to give written informed consent\n\nExclusion Criteria (participants must not):\n\n* Have history of BCa\n* History of previous cancer (excluding basal and squamous cell skin cancer)\n* Have a known active urinary tract infection or urinary retention\n* Have active stone disease (renal or bladder) or renal insufficiency (creatinine \\>2.0 mg\u002FdL)\n* Have ureteral stents, nephrostomy tubes or bowel interposition\n* Have recent genitourinary instrumentation (within 10 days prior to signing consent)\n* Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)",[52,53],"ADULT","OLDER_ADULT",[55,69,83,91,103,115,127,138],{"facility":56,"status":7,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":66},"VA Long Beach Healthcare System","Long Beach","California","90822","United States",[62],{"name":63,"role":64,"email":65},"Mina Behdad","CONTACT","Mina.Behdad@va.gov",{"lat":67,"lon":68},33.76696,-118.18923,{"facility":12,"status":7,"city":70,"state":58,"zip":71,"country":60,"contacts":72,"geoPoint":80},"Los Angeles","90048",[73,77],{"name":74,"role":64,"phone":75,"email":76},"Amy Oppenheim","310-423-3713","Amy.Oppenheim@cshs.org",{"name":78,"role":79},"Hideki Furuya, PhD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},34.05223,-118.24368,{"facility":84,"status":7,"city":70,"state":58,"zip":85,"country":60,"contacts":86,"geoPoint":90},"UCLA Medical Center","90095",[87],{"name":88,"role":64,"email":89},"Ankush Sachdeva","asachdeva@mednet.ucla.edu",{"lat":81,"lon":82},{"facility":92,"status":7,"city":93,"state":58,"zip":94,"country":60,"contacts":95,"geoPoint":100},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",[96],{"name":97,"role":64,"phone":98,"email":99},"Clemente Reyes","949-791-3049","clemente.reyesrodriguez@hoag.org",{"lat":101,"lon":102},33.61891,-117.92895,{"facility":104,"status":7,"city":105,"state":106,"zip":107,"country":60,"contacts":108,"geoPoint":112},"University of Rochester Medical Center","Rochester","New York","14620",[109],{"name":110,"role":64,"email":111},"Natalie Carroll","Natalie_Carroll@URMC.Rochester.edu",{"lat":113,"lon":114},43.15478,-77.61556,{"facility":116,"status":7,"city":117,"state":118,"zip":119,"country":60,"contacts":120,"geoPoint":124},"UT Southwestern Medical Center at Dallas","Dallas","Texas","75390",[121],{"name":122,"role":64,"email":123},"Maricruz Ibarra","Maricruz.Ibarra@UTSouthwestern.edu",{"lat":125,"lon":126},32.78306,-96.80667,{"facility":128,"status":7,"city":129,"state":129,"zip":130,"country":131,"contacts":132,"geoPoint":135},"Nara Prefecture Seiwa Medical Center","Nara","636-0802","Japan",[133],{"name":134,"role":64},"Satoshi Anai, MD",{"lat":136,"lon":137},34.68505,135.80485,{"facility":139,"status":7,"city":129,"country":131,"contacts":140,"geoPoint":143},"Nara Medical University",[141],{"name":142,"role":64},"Takuto Shimizu, MD",{"lat":136,"lon":137},[145],{"name":146,"role":64,"phone":147,"email":148},"Charles Rosser, MD","310-423-5609","charles.rosser@cshs.org",[150,153],{"name":146,"affiliation":151,"role":152},"Nonagen Bioscience Corporation","STUDY_DIRECTOR",{"name":78,"affiliation":12,"role":79},[155,159,162],{"pmid":156,"type":157,"citation":158},"42106837","DERIVED","Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9;24(1):791. doi: 10.1186\u002Fs12967-026-08245-4.",{"pmid":160,"type":157,"citation":161},"38167321","Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186\u002Fs12967-023-04811-2.",{"pmid":163,"type":157,"citation":164},"38045238","Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203\u002Frs.3.rs-3635581\u002Fv1.",[],{"nct_id":4,"conditions":167,"biomarkers":169},[168],"Bladder Carcinoma",[],{"nct_id":4,"found":14,"summary":171,"prompt_version":181},{"design":172,"status":173,"heading":174,"summary":175,"follow_up":176,"word_count":177,"commitments":178,"compensation":179,"drugs_mentioned":180},"This is an observational study, meaning researchers will observe and collect data without providing any specific intervention. It aims to enroll approximately 900 participants.","completed","Evaluating a New Test for Bladder Cancer in Patients with Microscopic Hematuria","This study is testing a new way to detect bladder cancer (BCa) non-invasively. Researchers are evaluating a multiplex ELISA assay, which is a type of lab test, using urine samples from people who have microscopic hematuria (blood in the urine that can only be seen under a microscope). The goal is to see if this new test can accurately identify bladder cancer, which is currently often missed by other urine tests. The study aims to enroll about 900 participants aged 18 to 90 years old who have had microscopic hematuria within the last three months and are willing to give their consent. Success will be measured by how well the test's sensitivity and specificity (its ability to correctly identify those with and without bladder cancer) are confirmed by a cystoscopy (an invasive procedure where a camera is inserted into the bladder) after one year. The current recruitment status is unclear.","The primary endpoint, which measures the test's accuracy, will be assessed at 1 year.",150,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]