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Bladder CancerNCT05508568

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

An observational study of Bladder Cancer, run by Arquer Diagnostics Ltd at 13 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
ADXBLADDER
How many people
650 participants
Where
13 sitesUnited States
Study dates
1 Jul 2021to Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country.

Jacqueline Stockley, PhD contact

+44 191 516 6764

jacqui@arquerdx.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • Clinical Research Solutions

    Cleveland, Ohio, 44130

    Lawrence A. Gervasi, MD

    Recruiting

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

    Martin K. Deneen, MD

    Recruiting

  • The Urology Center of Colorado

    Denver, Colorado, 80211

    Larry Karsh, MD

    Recruiting

  • First Urology

    Jeffersonville, Indiana, 47130

    James Bailen, MD

    Recruiting

  • New Jersey Urology

    Mount Laurel, New Jersey, 08054

    Louis Keeler, MD

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Neal Shore, MD

    Recruiting

  • MidLantic Urology

    Philadelphia, Pennsylvania, 19004

    Laurence Belkoff, MD

    Recruiting

  • Virginia Urology Center

    Richmond, Virginia, 23235

    Eugene Kramolowsky, MD

    Recruiting

  • Urology San Antonio

    San Antonio, Texas, 78229

    Jose De La Cerda, MD

    Recruiting

  • Spokane Urology

    Spokane, Washington, 99202

    Raymond Lance, MD

    Recruiting

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

    Christopher Pieczonka, MD

    Recruiting

  • Michigan Institute of Urology

    Troy, Michigan, 48084

    Jason Hafron, MD

    Recruiting

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

    Michael Williams, MD

    Recruiting

Other trials in United States

About this study

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
Being tested
ADXBLADDER
Keywords
Bladder Cancer, Non-muscle invasive bladder cancer, MCM5, Biomarker, Urinary biomarker, Follow-up, Surveillance
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADXBLADDERDiagnostic 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.

Study groups in NCT05508568
Study groupRoleWhat they receive
Non-muscle invasive bladder cancer patients in follow-upPatients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.
Receives: Diagnostic Test: ADXBLADDER

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start1 Jul 2021
  3. Primary completion1 Jan 2023
  4. Study completionApr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508568
Sponsor's protocol ID
Arquer-US1
Status last verified
Jan 2023
First submitted
17 Aug 2022
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 32314931

  • 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.

    PubMed 32745350

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by Arquer Diagnostics Ltd at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacqueline Stockley, PhD (+44 191 516 6764, jacqui@arquerdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508568, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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