Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT05508568
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2022-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine sediment lysate samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, specificity and negative predictive value (NPV) of ADXBLADDDER will be calculated to establish the diagnostic accuracy for the detection of bladder cancer recurrence.', 'timeFrame': 'Urine samples will be collected from participants immediately prior to cystoscopy and analysed for MCM5 within 6 months. Overall performance characteristics of ADXBLADDER will be established following study completion.', 'description': 'The ADXBLADDER MCM5 results will be compared with the definitive diagnosis obtained by gold standard cystoscopy and pathological assessment of suspicious lesion(s) (where clinically indicated).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'Non-muscle invasive bladder cancer', 'MCM5', 'Biomarker', 'Urinary biomarker', 'Follow-up', 'Surveillance'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '32314931', 'type': 'BACKGROUND', 'citation': 'Roupret M, Gontero P, McCracken SRC, Dudderidge T, Stockley J, Kennedy A, Rodriguez O, Sieverink C, Vanie F, Allasia M, Witjes JA, Colombel M, Sylvester R, Longo F, Montanari E, Palou J. Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Nonmuscle Invasive Bladder Cancer Followup: A Blinded, Prospective Cohort, Multicenter European Study. J Urol. 2020 Oct;204(4):685-690. doi: 10.1097/JU.0000000000001084. Epub 2020 Apr 21.'}, {'pmid': '32745350', 'type': 'BACKGROUND', 'citation': 'Gontero P, Montanari E, Roupret M, Longo F, Stockley J, Kennedy A, Rodriguez O, McCracken SRC, Dudderidge T, Sieverink C, Vanie F, Allasia M, Witjes JA, Sylvester R, Colombel M, Palou J. Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow-up of non-muscle-invasive bladder cancer: a blinded prospective multicentric study. BJU Int. 2021 Feb;127(2):198-204. doi: 10.1111/bju.15194. Epub 2020 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence. Patients undergoing cystoscopic surveillance in non-muscle invasive bladder cancer (NMIBC) follow-up will be recruited and asked to provide a urine sample to be tested with ADXBLADDER. To assess the diagnostic accuracy of the test, the MCM5 results will be compared with the gold standard cystoscopy and pathology of resected tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed with NMIBC in the previous 2 years, and are attending the urology clinic for standard of care/routine monitoring cystoscopy\n* Patients 22 years of age or older\n* Patients who, in the opinion of the Investigator, are suitable for standard urological investigations as part of normal clinical practice\n* Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen\n* Patients who are able to give voluntary, written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients with known active (symptomatic) calculi within the urino-genitary system\n* Patients who provide less than 10mL of full void urine\n* Patients undergoing active treatment for interstitial cystitis\n* Patients currently undergoing systemic chemotherapy or systemic immunotherapy or radiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed\n* Patients who have previously been diagnosed with renal cancer, prostate cancer, Muscle Invasive Bladder cancer, an upper tract tumour, or CiS in the prostatic urethra\n* Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test\n* Male patients undergoing active treatment for prostatitis'}, 'identificationModule': {'nctId': 'NCT05508568', 'briefTitle': "A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer", 'organization': {'class': 'INDUSTRY', 'fullName': 'Arquer Diagnostics Ltd'}, 'officialTitle': "A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer", 'orgStudyIdInfo': {'id': 'Arquer-US1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-muscle invasive bladder cancer patients in follow-up', 'description': 'Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.', 'interventionNames': ['Diagnostic Test: ADXBLADDER']}], 'interventions': [{'name': 'ADXBLADDER', 'type': 'DIAGNOSTIC_TEST', 'description': 'ADXBLADDER is a non-invasive, qualitative ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the monitoring of bladder cancer recurrence in non-muscle-invasive bladder cancer patients. Participants will be asked to provide a full void urine specimen, which will be centrifuged before the urine sediment is lysed. The lysed sample will then be tested with ADXBLADDER.', 'armGroupLabels': ['Non-muscle invasive bladder cancer patients in follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80211', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larry Karsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Urology Center of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Martin K. Deneen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advanced Urology Institute', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Bailen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Urology', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Hafron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michigan Institute of Urology', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '08054', 'city': 'Mount Laurel', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louis Keeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Jersey Urology', 'geoPoint': {'lat': 39.934, 'lon': -74.891}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Pieczonka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Associated Medical Professionals of NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '44130', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lawrence A. Gervasi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Solutions', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19004', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurence Belkoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MidLantic Urology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neal Shore, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose De La Cerda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eugene Kramolowsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Urology Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Williams, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raymond Lance, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spokane Urology', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'centralContacts': [{'name': 'Jacqueline Stockley, PhD', 'role': 'CONTACT', 'email': 'jacqui@arquerdx.com', 'phone': '+44 191 516 6764'}], 'overallOfficials': [{'name': 'Professor Ashish Kamat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas MD Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arquer Diagnostics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}