A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508568
• Other study ID #: Arquer-US1
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: April 2023

Study information

• Verified date: January 2023
• Source: Arquer Diagnostics Ltd
• Contact: Jacqueline Stockley, PhD
• Phone: +44 191 516 6764
• Email: jacqui[@]arquerdx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: April 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Clinical Research Solutions	Cleveland	Ohio
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	The Urology Center of Colorado	Denver	Colorado
United States	First Urology	Jeffersonville	Indiana
United States	New Jersey Urology	Mount Laurel	New Jersey
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	MidLantic Urology	Philadelphia	Pennsylvania
United States	Virginia Urology Center	Richmond	Virginia
United States	Urology San Antonio	San Antonio	Texas
United States	Spokane Urology	Spokane	Washington
United States	Associated Medical Professionals of NY	Syracuse	New York
United States	Michigan Institute of Urology	Troy	Michigan
United States	Urology of Virginia	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Arquer Diagnostics Ltd

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity and negative predictive value (NPV) of ADXBLADDDER will be calculated to establish the diagnostic accuracy for the detection of bladder cancer recurrence.	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).	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.