[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pacific Edge Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100546433","study-to-assess-the-impact-of-the-urine-test-cxbladder-triage-plus-on-the-number-of-cystoscopies-performed-on-patients-with-invisible-blood-in-their-urine-100546433",false,"NCT06394869","Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.","Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)","CREDIBLE","Inclusion Criteria:\n\n1. Patient is referred for assessment of recent hematuria, defined as either:\n\n   1. Microscopic hematuria (≥3 RBC\u002FHPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR\n   2. Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with urine microscopy collected on the same day as enrollment\n2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.\n3. Able to give informed, written consent.\n4. Able and willing to comply with study requirements.\n5. Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.\n6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions.\n\nExclusion Criteria:\n\n1. Prior history of bladder malignancy.\n2. Prior history of upper tract UC or prostatic urethral UC.\n3. History of gross hematuria requiring instrumentation or hospitalization within the last 12 months\n4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)\n5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).\n6. Cystoscopy contraindicated due to another condition or anatomy.\n7. History of pelvic radiation.\n8. Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks.\n9. History of schistosomiasis.\n10. History of chronic (\\>3 months) indwelling Foley catheter or chronic (\\>3 months) bladder stones.\n11. Known current pregnancy","ALL","18 Years","88 Years",{"count":21,"type":22},1000,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients.\n\nMost microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine.\n\nThis study is conducted to find out if the use of \"Cxbladder Triage Plus\" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called \"Triage Plus\". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients.\n\nThe study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Triage Plus result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy.\n\nFor test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Triage Plus result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. The survey has only one question. It is asking for the reasons of the decision.\n\nAfter making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months.\n\nTo see how Triage Plus changes the number of cystoscopies, these will be counted in each group and then compared.",[28],"Hematuria - Cause Not Known",[30,31,32,33],"microscopic hematuria","microhematuria","urothelial carcinoma","bladder cancer","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2025-04-29",{"date":42,"type":22},"2028-04",{"name":44,"class":45},"Pacific Edge Limited","INDUSTRY",20,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":72},"100507577","detection-and-risk-stratification-in-veterans-presenting-with-microscopic-hematuria-100507577","NCT05889195","Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria","Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)","microDRIVE","Inclusion Criteria:\n\n1. Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria:\n\n   EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC\u002FHPF (or equivalent). OR: (b) Gross hematuria.\n2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.\n3. Able to give informed, written consent.\n4. Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) \u002F tube labels and ship urine back to the central laboratory using a prepaid courier service).\n5. Aged 18 years or older.\n\nFootnotes:\n\n1. For the microscopic hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder. ii) Patients who are considered high risk by the AUA 2020 guidelines.\n2. For gross hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder\n\nExclusion Criteria:\n\n1. Prior history of bladder malignancy.\n2. Reported Cxbladder results within the last six months.\n3. Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.\n4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).\n5. Subjects aged 89 years of age or older.\n6. Subjects with a history of pelvic radiation.\n7. Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks.\n8. Subjects with renal failure on dialysis.\n9. History of schistosomiasis.\n10. Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.","89 Years",{"count":21,"type":22},"OBSERVATIONAL","It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.",[60],"Urothelial Carcinoma",[60,30,62,63,64],"Cxbladder","Urine test","genomic test","2026-04-21",{"date":67,"type":38},"2026-04-24",{"date":69,"type":38},"2023-11-02",{"date":35,"type":22},{"name":44,"class":45},4,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100445481","longitudinal-bladder-cancer-study-for-tumour-recurrence-100445481","NCT05080998","Longitudinal Bladder Cancer Study for Tumour Recurrence","An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients","LOBSTER","Inclusion Criteria:\n\n1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.\n2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit.\n3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible).\n4. Able to give written informed consent\n5. Able and willing to comply with study requirements\n6. Aged 18 years or older\n\nExclusion Criteria:\n\n1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits\n2. Previous muscle invasive bladder tumour (pT2 or greater)\n3. Known pregnancy\n\nDeferral Criteria\n\n1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.\n2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.\n3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.",{"count":82,"type":22},450,"Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.",[85],"Urothelial Bladder Cancer",[87],"Recurrence","2025-11-06",{"date":90,"type":38},"2025-11-10",{"date":92,"type":38},"2022-06-08",{"date":94,"type":22},"2026-08-31",{"name":44,"class":45},7,""]