SOLUSION: Urine-based Detection of Non-muscle Invasive Bladder
Study Details
Study Description
Brief 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. 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%).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: Flexcystoscopy Control cystoscopy every 3 months as a standard procedure |
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Active Comparator: Uine biomarker Urine test every 3 months |
Diagnostic Test: Urine test
Urine test will be taken every three months after first resection of bladder tumor
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Outcome Measures
Primary Outcome Measures
- Recurrences rate [5 years]
Recurrences rate
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who previously had low grad NMIBC.
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No recurrence at cystoscopy at the time of inclusion in the study
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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:
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Clinical suspicion of muscle invasive bladder cancer
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Upper urinary track tumours
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Patients undergoing neoadjuvant chemotherapy based on local protocols
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Metastatic urothelial carcinoma
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Patients recived installation therapy within the last 4 weeks
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Zealand University Hospital | Roskilde | Denmark | 4000 |
Sponsors and Collaborators
- Nessn Azawi
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOLUSION