Urine-based Detection of Non-muscle Invasive Bladder

Overview

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).

Full Title of Study: “Urine-based Detection of Non-muscle Invasive Bladder Cancer Recurrence”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 1, 2023

Detailed Description

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%). Hypothesis: The study aims at evaluating the potential clinical impact of a highly sensitive urinary marker, Uromonitor, regarding possible reduction in number of cystoscopies. We hypothesize that the use of a sensitive urinary marker regarding recurrent tumor will enable us to reduce the number of follow-up cystoscopies without risk of delaying diagnosis of recurrence and progression cystoscopies compared to flexible cystoscopy alone. We hypothesize that number of tumors missed at follow-up cystoscopy alone or urinary marker alone is identical or in favor of a sensitive urinary marker that can detect sub-visible lesions and the examinations combined identify all tumor recurrences. Moreover, we hypothesize that tumors missed at follow-up at a given time point are very small and will be identified at next follow-up without increasing the risk of progression and that regular follow-up with cystoscopy alone therefore can be replaced by follow-up with a sensitive urinary biomarker alone – where cystoscopy only is performed if the biomarker is positive.

Arms, Groups and Cohorts

  • Flexcystoscopy/Uromonitor
    • Control cystoscopy every 4 – 8 and 12 months as a standard procedure, And Urine test (Uromonitor) every 4 months

Clinical Trial Outcome Measures

Primary Measures

  • Recurrences rate
    • Time Frame: 5 years
    • Recurrences rate

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who previously had low grad NMIBC. – Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Exclusion Criteria:

  • Clinical suspicion of muscle invasive bladder cancer – Upper urinary track tumours – Patients undergoing neoadjuvant chemotherapy based on local protocols – Metastatic urothelial carcinoma – Patients recived installation therapy within the last 4 weeks

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nessn Azawi
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Nessn Azawi, Associate professor – Zealand University Hospital

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