Clinical trial · Observational
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
NCT05508568CI-TRIAL-00063588unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADXBLADDER | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-muscle invasive bladder cancer patients in follow-up
- description
- Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.
- interventionNames
- Diagnostic Test: ADXBLADDER
Primary outcomes (1)
- 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.
- timeFrame
- 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.
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDRoupret 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
- BACKGROUNDGontero 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