A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT05508568. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05508568
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 650 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2021
- Primary completion
- Dec 31, 2022
- Completion
- Mar 31, 2023
- Last update posted
- Jan 31, 2023
2021 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Urology Center of Colorado | Denver | Colorado | 80211 | Recruiting |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | Recruiting |
| First Urology | Jeffersonville | Indiana | 47130 | Recruiting |
| Michigan Institute of Urology | Troy | Michigan | 48084 | Recruiting |
| New Jersey Urology | Mount Laurel | New Jersey | 08054 | Recruiting |
| Associated Medical Professionals of NY | Syracuse | New York | 13210 | Recruiting |
| Clinical Research Solutions | Cleveland | Ohio | 44130 | Recruiting |
| MidLantic Urology | Philadelphia | Pennsylvania | 19004 | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Urology San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Virginia Urology Center | Richmond | Virginia | 23235 | Recruiting |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | Recruiting |
| Spokane Urology | Spokane | Washington | 99202 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05508568, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05508568 live on ClinicalTrials.gov.