Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02700659
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2016-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cxbladder Monitoring Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'De-identified, consented participant samples of between 5mL and 15 mL of urine, stabilized in the proprietary Cxbladder liquid, will be stored at -80ºC for further urinary diagnostic assay development and improvement.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 803}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2016-01-13', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.', 'timeFrame': 'The outcome measure will be assessed by 6 months after trial completion.', 'description': 'The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.'}, {'measure': 'Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.', 'timeFrame': 'The outcome measure will be assessed by 6 months after trial completion.'}], 'secondaryOutcomes': [{'measure': "Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology.", 'timeFrame': 'The outcome measure will be assessed by 6 months after trial completion.', 'description': 'Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.'}, {'measure': "Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 ELISA Assay.", 'timeFrame': 'The outcome measure will be assessed by 6 months after trial completion.', 'description': 'Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 ELISA, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.'}, {'measure': "Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of NMP22 BladderChek Assay.", 'timeFrame': 'The outcome measure will be assessed by 6 months after trial completion.', 'description': 'Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 BladderChek, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32700139', 'type': 'DERIVED', 'citation': "Lough T, Luo Q, O'Sullivan P, Chemasle C, Stotzer M, Suttie J, Darling D. Clinical Utility of Cxbladder Monitor for Patients with a History of Urothelial Carcinoma: A Physician-Patient Real-World Clinical Data Analysis. Oncol Ther. 2018 Jun;6(1):73-85. doi: 10.1007/s40487-018-0059-5. Epub 2018 Apr 19."}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy.\n\nThe gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were recruited from community and referral centres. Patients were under surveillance for recurring urothelial carcinoma monitoring, and undergoing all standard of care, including investigative cystoscopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed positive diagnosis for primary or recurrent urinary tract UC over the past 2 years.\n* Patient is undergoing investigative cystoscopies for the monitoring of recurrence of UC at intervals prescribed by a clinical practitioner\n* Patient is 18 years of age or older.\n\nExclusion Criteria:\n\n* Prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis\n* Patient has undergone total bladder cystectomy as treatment for bladder UC'}, 'identificationModule': {'nctId': 'NCT02700659', 'briefTitle': 'The Cxbladder Monitoring Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacific Edge Limited'}, 'officialTitle': 'A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)', 'orgStudyIdInfo': {'id': 'Cxb-012-EXP-013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UC monitoring patients', 'description': 'Patients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations.\n\nAll patients will have urine samples taken and analyzed for NMP22 ELISA, NMP22 BladderChek, urine cytology and Cxbladder.\n\nNo results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes.', 'interventionNames': ['Other: Cxbladder']}], 'interventions': [{'name': 'Cxbladder', 'type': 'OTHER', 'description': 'Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.', 'armGroupLabels': ['UC monitoring patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '06052', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Urology Center of Grove Hill, One Lake Street', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Urology Associates', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Urologic Institute', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '08054', 'city': 'New Jersey', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Urology, LLC'}, {'zip': '12401', 'city': 'Kingston', 'state': 'New York', 'country': 'United States', 'facility': 'Premier Medical Group of the Hudson Valley', 'geoPoint': {'lat': 41.92704, 'lon': -73.99736}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College, Department of Urology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12061', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Premier Medical Group of the Hudson Valley', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12550', 'city': 'Newburgh', 'state': 'New York', 'country': 'United States', 'facility': 'Premier Medical Group of the Hudson Valley', 'geoPoint': {'lat': 41.50343, 'lon': -74.01042}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center and College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': "Paul J O'Sullivan, PhD", 'role': 'STUDY_CHAIR', 'affiliation': 'Pacific Edge Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacific Edge Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}