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Non-muscle invasive bladder cancer patients in follow-up for Bladder Cancer

N/A
Recruiting
Led By Professor Ashish Kamat
Research Sponsored by Arquer Diagnostics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

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.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity, specificity and negative predictive value (NPV) of ADXBLADDDER will be calculated to establish the diagnostic accuracy for the detection of bladder cancer recurrence.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-muscle invasive bladder cancer patients in follow-upExperimental Treatment1 Intervention
Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.

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Who is running the clinical trial?

Arquer Diagnostics LtdLead Sponsor
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Professor Ashish KamatPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
~156 spots leftby Sep 2025
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