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

Arquer Diagnostics Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05508568

Collaborator

(none)

650

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Diagnostic Test: ADXBLADDER

Study Design

Study Type:

Observational

Anticipated Enrollment :

650 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Sensitivity, specificity and negative predictive value (NPV) of ADXBLADDDER will be calculated to establish the diagnostic accuracy for the detection of bladder cancer recurrence. [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.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Urology Center of Colorado	Denver	Colorado	United States	80211
2	Advanced Urology Institute	Daytona Beach	Florida	United States	32114
3	First Urology	Jeffersonville	Indiana	United States	47130
4	Michigan Institute of Urology	Troy	Michigan	United States	48084
5	New Jersey Urology	Mount Laurel	New Jersey	United States	08054
6	Associated Medical Professionals of NY	Syracuse	New York	United States	13210
7	Clinical Research Solutions	Cleveland	Ohio	United States	44130
8	MidLantic Urology	Philadelphia	Pennsylvania	United States	19004
9	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
10	Urology San Antonio	San Antonio	Texas	United States	78229
11	Virginia Urology Center	Richmond	Virginia	United States	23235
12	Urology of Virginia	Virginia Beach	Virginia	United States	23462
13	Spokane Urology	Spokane	Washington	United States	99202