Urine-based Detection of Non-muscle Invasive Bladder

  • STATUS
    Recruiting
  • End date
    Aug 1, 2027
  • participants needed
    533
  • sponsor
    Nessn Azawi
Updated on 30 September 2021
cancer
bladder cancer
invasive bladder cancer
cystoscopy
bladder tumor

Summary

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. Its 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%).

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. Its 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.

Details
Condition Bladder Carcinoma, Bladder Disorders, Urologic Cancer, carcinoma of the bladder, bladder cancer, Urothelial Cancer, bladder disorder, urinary tract neoplasm, Bladder Cancer, bladder tumor
Treatment Urine test
Clinical Study IdentifierNCT03962933
SponsorNessn Azawi
Last Modified on30 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who previously had low grad NMIBC
No recurrence at cystoscopy at the time of inclusion in the study
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
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