A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
NCT ID: NCT05508568
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
650 participants
OBSERVATIONAL
2021-07-01
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-muscle invasive bladder cancer patients in follow-up
Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.
ADXBLADDER
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.
Interventions
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ADXBLADDER
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.
Eligibility Criteria
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Inclusion Criteria
* Patients 22 years of age or older
* Patients who, in the opinion of the Investigator, are suitable for standard urological investigations as part of normal clinical practice
* Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
* Patients who are able to give voluntary, written informed consent to participate in this study
Exclusion Criteria
* Patients who provide less than 10mL of full void urine
* Patients undergoing active treatment for interstitial cystitis
* Patients currently undergoing systemic chemotherapy or systemic immunotherapy or radiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed
* 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
* Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test
* Male patients undergoing active treatment for prostatitis
22 Years
ALL
No
Sponsors
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Arquer Diagnostics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Ashish Kamat
Role: PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Locations
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The Urology Center of Colorado
Denver, Colorado, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
First Urology
Jeffersonville, Indiana, United States
Michigan Institute of Urology
Troy, Michigan, United States
New Jersey Urology
Mount Laurel, New Jersey, United States
Associated Medical Professionals of NY
Syracuse, New York, United States
Clinical Research Solutions
Cleveland, Ohio, United States
MidLantic Urology
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology San Antonio
San Antonio, Texas, United States
Virginia Urology Center
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Spokane Urology
Spokane, Washington, United States
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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Arquer-US1
Identifier Type: -
Identifier Source: org_study_id
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