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

NCT05508568 | Unknown FDA Device

• 1 other identifier: Arquer-US1
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 13

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

ADXBLADDER DIAGNOSTIC_TEST

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.

Non-muscle invasive bladder cancer patients in follow-up

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arquer Diagnostics Ltd: lead

Study Sites (13)

The Urology Center of Colorado

Denver, Colorado, 80211, United States

RECRUITING

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

RECRUITING

First Urology

Jeffersonville, Indiana, 47130, United States

RECRUITING

Michigan Institute of Urology

Troy, Michigan, 48084, United States

RECRUITING

New Jersey Urology

Mount Laurel, New Jersey, 08054, United States

RECRUITING

Associated Medical Professionals of NY

Syracuse, New York, 13210, United States

RECRUITING

Clinical Research Solutions

Cleveland, Ohio, 44130, United States

RECRUITING

MidLantic Urology

Philadelphia, Pennsylvania, 19004, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Virginia Urology Center

Richmond, Virginia, 23235, United States

RECRUITING

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

RECRUITING

Spokane Urology

Spokane, Washington, 99202, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 32314931 BACKGROUND

• 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.

  PMID: 32745350 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sediment lysate samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Professor Ashish Kamat

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Stockley, PhD

CONTACT

+44 191 516 6764; jacqui@arquerdx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: July 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)