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

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT05508568
• Lead Sponsor: Arquer Diagnostics Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (13)

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

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