{"protocolSection":{"identificationModule":{"nctId":"NCT03193541","orgStudyIdInfo":{"id":"Rosser-2015-8"},"briefTitle":"A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer","officialTitle":"A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer"},"descriptionModule":{"briefSummary":"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.","detailedDescription":"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."},"conditionsModule":{"conditions":["Bladder Cancer"]},"eligibilityModule":{"eligibilityCriteria":"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/dL)\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)","sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"Adults, age 18 and older who have documented microscopic hematuria within the past 3 months who are referred for cystoscopy and are willing to participate","samplingMethod":"NON_PROBABILITY_SAMPLE"}}}