Recruiting

MCM5 Elisa TestA 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

Code:

NCT05508568

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

ADXBLADDER

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT05508568

Start date

Jul 1, 2021

Status verified date

Jan, 2023

Completion date

Apr, 2023

Anticipated

Primary completion date

Jan 1, 2023

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome 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. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Jacqueline Stockley, PhD

+44 191 516 6764 jacqui@arquerdx.com

Locations

The Urology Center of Colorado

Recruiting

Denver, Colorado, United States, 80211

Principal Investigator:

Larry Karsh, MD

Advanced Urology Institute

Recruiting

Daytona Beach, Florida, United States, 32114

Principal Investigator:

Martin K. Deneen, MD

First Urology

Recruiting

Jeffersonville, Indiana, United States, 47130

Principal Investigator:

James Bailen, MD

Michigan Institute of Urology

Recruiting

Troy, Michigan, United States, 48084

Principal Investigator:

Jason Hafron, MD

New Jersey Urology

Recruiting

Mount Laurel, New Jersey, United States, 08054

Principal Investigator:

Louis Keeler, MD

Associated Medical Professionals of NY

Recruiting

Syracuse, New York, United States, 13210

Principal Investigator:

Christopher Pieczonka, MD

Clinical Research Solutions

Recruiting

Cleveland, Ohio, United States, 44130

Principal Investigator:

Lawrence A. Gervasi, MD

MidLantic Urology

Recruiting

Philadelphia, Pennsylvania, United States, 19004

Principal Investigator:

Laurence Belkoff, MD

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Principal Investigator:

Neal Shore, MD

Urology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Jose De La Cerda, MD

Virginia Urology Center

Recruiting

Richmond, Virginia, United States, 23235

Principal Investigator:

Eugene Kramolowsky, MD

Urology of Virginia

Recruiting

Virginia Beach, Virginia, United States, 23462

Principal Investigator:

Michael Williams, MD

Spokane Urology

Recruiting

Spokane, Washington, United States, 99202

Principal Investigator:

Raymond Lance, MD

More Information

Sponsor

Arquer Diagnostics Ltd

Last update posted

Feb 1, 2023

Last verified

Jan, 2023

Keywords

Bladder Cancer
Non-muscle invasive bladder cancer
MCM5
Biomarker
Urinary biomarker
Follow-up
Surveillance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arquer Diagnostics Ltd on 2023-02-01.