Clinical trial NCT05508568: A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Official 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Non-muscle invasive bladder cancer
MCM5
Biomarker
Urinary biomarker
Follow-up
Surveillance
Lead sponsor: Arquer Diagnostics Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 650
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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 with known active (symptomatic) calculi within the urino-genitary system
* 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

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Mount Laurel
country: United States
facility: New Jersey Urology
state: New Jersey
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Cleveland
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Philadelphia
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Professor Ashish Kamat
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.