Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT06394869
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2024-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2024-04-21', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Detection of urothelial carcinoma (UC)', 'timeFrame': 'At the end of the current investigation, i.e. when a diagnosis was made or it was decided not to perform diagnostic procedures other than surveillance. Expected within approximately 120 days after sampling.', 'description': 'Difference in the proportion of UCs found in each arm.'}, {'measure': 'Cxbladder Triage Plus performance and test negative rate.', 'timeFrame': 'At the end of the current investigation, i.e. when a diagnosis was made.', 'description': 'Number of false positive, true positive, false negative and true negative test results when comparing the Triage Plus result to the results of histopathologically confirmed cystoscopy.'}, {'measure': 'Persistent hematuria.', 'timeFrame': 'At urinalysis 90-180 days (of the decision to proceed with surveillance)', 'description': 'Rate of persistent hematuria in patients choosing surveillance.'}, {'measure': 'Physician rationale', 'timeFrame': 'After reviewing the Detect+ result and giving their recommendation, before cystoscopy (if applicable). Expected once and within 90 days of sampling', 'description': 'Physician-reported reasons for not following the study recommended pathway based on the Detect+ result.'}, {'measure': 'Patient rationale', 'timeFrame': 'After discussing the Detect+ result with the investigator, before cystoscopy (if applicable). Expected once and within 90 days of sampling .', 'description': 'Patient-reported reasons for not following the investigator recommended pathway.'}, {'measure': 'Imaging Rates', 'timeFrame': '3-months prior to 6-months post enrollment', 'description': 'Change in imaging rates between arms'}], 'primaryOutcomes': [{'measure': 'Cystoscopy rate', 'timeFrame': '3 months from the decision to perform or not perform cystoscopy.', 'description': 'Difference in the proportion of cystoscopies performed in each arm.'}], 'secondaryOutcomes': [{'measure': 'Rate of imaging procedures', 'timeFrame': '3 months from the decision to perform or not perform cystoscopy.', 'description': 'Sub-analyses on AUA risk categories for primary and secondary objectives'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microscopic hematuria', 'microhematuria', 'urothelial carcinoma', 'bladder cancer'], 'conditions': ['Hematuria - Cause Not Known']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is referred for assessment of microhematuria (MH) with presentation confirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 6-months of 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. Gross hematuria within the last twelve months (reported in patient's records and/or during patient's interview)\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"}, 'identificationModule': {'nctId': 'NCT06394869', 'acronym': 'CREDIBLE', 'briefTitle': '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.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacific Edge Limited'}, 'officialTitle': 'Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)', 'orgStudyIdInfo': {'id': 'CXB/2024/CREDIBLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Arm', 'description': 'The site will receive the Cxbladder Detect+ result and the urologist study investigator discuss it with the patient before making a shared decision whether or not to proceed with cystoscopy.', 'interventionNames': ['Diagnostic Test: Cxbladder Triage Plus']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Neither the site nor the patient will receive the Cxbladder Detect+ result. The decision whether or not to proceed with cystoscopy will be made following standard of care.'}], 'interventions': [{'name': 'Cxbladder Triage Plus', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cxbladder Triage Plus is a lab developed, test that is using RNA and DNA biomarkers in the urine to assess the likelihood of the presence of urothelial carcinoma in the bladder.', 'armGroupLabels': ['Test Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meredith A Sharpton, PA-C', 'role': 'CONTACT', 'email': 'msharpton@urologyal.com', 'phone': '205-445-0129'}, {'name': 'Rita Aderholt, CCRC', 'role': 'CONTACT', 'email': 'raderholt@urologyal.com', 'phone': '205-445-0124'}, {'name': 'Andrew Strang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology Centers of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pamela R Manley', 'role': 'CONTACT', 'email': 'pmanley@uampa.com', 'phone': '251-234-5933'}, {'name': 'Letoya Craig', 'role': 'CONTACT', 'email': 'lcraig@uampa.com', 'phone': '251-234-5933'}, {'name': 'Charles F White, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology Associates of Mobile', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Lawindy, MD', 'role': 'CONTACT', 'email': 'samuel.lawindy@auihealth.com', 'phone': '3862398500'}, {'name': 'Samuel Lawindy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advanced Urology Institute - Daytona Beach', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '46410', 'city': 'Merrillville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shawna Clemons', 'role': 'CONTACT', 'email': 'sclemons@urologis-specialists.com', 'phone': '2107698641'}, {'name': 'Michelle Ramos', 'role': 'CONTACT', 'email': 'mramos@urologic-specialists.com', 'phone': '2192591291'}, {'name': 'Manoj Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urologic Specialists of Northwest Indiana', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thad Bourque Dr, MD', 'role': 'CONTACT', 'email': 'tbourque@ssmsla.com', 'phone': '3374223770'}, {'name': 'Simone Olivier', 'role': 'CONTACT', 'email': 'solivier@ssmsla.com', 'phone': '3374223770'}, {'name': 'Thad Bourque, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Urology', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '21076', 'city': 'Hanover', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rian J Dickstein, MD', 'role': 'CONTACT', 'email': 'rdickstein@chesuro.com', 'phone': '443-231-1313'}, {'name': 'Rian J Dickstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chesapeake Urology Research Associates', 'geoPoint': {'lat': 39.19289, 'lon': -76.72414}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alice Drew', 'role': 'CONTACT', 'email': 'adrew@summithealth.com', 'phone': '856-900-6753'}, {'name': 'Kelley Mauro', 'role': 'CONTACT', 'email': 'kmauro@summithealth.com', 'phone': '856-673-1613'}, {'name': 'Gordon A Brown, DO, BA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Summit Health', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adrien N Bernstein, MD', 'role': 'CONTACT', 'email': 'AMCurologyresearch@amc.edu', 'phone': '518-262-8579'}, {'name': 'Laura Davey, CCRC', 'role': 'CONTACT', 'email': 'AMCurologyresearch@amc.edu', 'phone': '518-262-8579'}, {'name': 'Adrien N Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albany MED Health System', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11042', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Yang', 'role': 'CONTACT', 'email': 'myang@imppllc.com', 'phone': '9174093932'}, {'name': 'Jed Kaminetsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Integrated Medical Professionals', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Cotton, RN, BSN, CCRC', 'role': 'CONTACT', 'email': 'lgrey@premiermedicalhv.com', 'phone': '845-437-3082'}, {'name': 'Jennifer Rose, LPN, CRC', 'role': 'CONTACT', 'email': 'jrose@premiermedicalhv.com', 'phone': '845-437-5082'}, {'name': 'Evan R Goldfischer, MD, FACS, CPE, CPI, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Premier Medical Group of the Hudson Valley, P. C.', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sneha Patel', 'role': 'CONTACT', 'email': 'urologyresearch@pennstatehealth.psu.edu', 'phone': '717-531-0003', 'phoneExt': '283173'}, {'name': 'Jay D Raman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Penn State Medical Center, Urology Research', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Baggett', 'role': 'CONTACT', 'email': 'ambaggett@ua-pc.com', 'phone': '615-250-9318'}, {'name': 'Christian Kindred', 'role': 'CONTACT', 'email': 'ctkindred@ua-pc.com', 'phone': '615-250-9319'}, {'name': 'Gautam Jayram, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology Associates, P. C.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristen R Scarpato, MD', 'role': 'CONTACT', 'email': 'Kristen.r.scarpato@vumc.com', 'phone': '615.343.2120'}, {'name': 'Kristen R Scarpato, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Perla Lopez', 'role': 'CONTACT', 'email': 'Perla.Lopez@UTSouthwestern.edu', 'phone': '2146459195'}, {'name': 'Maricruz Ibarra', 'role': 'CONTACT', 'email': 'Maricruz.Ibarra@UTSouthwestern.edu', 'phone': '2146458787'}, {'name': 'Yair Lotan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Marrah', 'role': 'CONTACT', 'email': 'marrah@urology.wisc.edu', 'phone': '608-262-3241'}, {'name': 'Abigail Wiedmer', 'role': 'CONTACT', 'email': 'wiedmer@urology.wisc.edu', 'phone': '608-265-9172'}, {'name': 'Kyle Richards', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Donna Smith', 'role': 'CONTACT', 'email': 'Donna.Smith@pacificedgedx.com', 'phone': '+64212436696'}, {'name': 'Tony Lough, PhD', 'role': 'CONTACT', 'email': 'tony.lough@pelnz.com', 'phone': '+64 (0)21 0223 8591'}], 'overallOfficials': [{'name': 'Tony Lough, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pacific Edge Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacific Edge Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}