Urine-based Detection of Non-muscle Invasive Bladder (SOLUSION)
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|ClinicalTrials.gov Identifier: NCT03962933|
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Diagnostic Test: Urine test||Not Applicable|
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%).
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||533 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Urine-based Detection of Non-muscle Invasive Bladder Cancer Recurrence|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||August 1, 2025|
|Estimated Study Completion Date :||August 1, 2027|
No Intervention: Flexcystoscopy
Control cystoscopy every 3 months as a standard procedure
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
- Recurrences rate [ Time Frame: 5 years ]Recurrences rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962933
|Zealand University Hospital||Recruiting|
|Roskilde, Denmark, 4000|
|Contact: Nessn H. Azawi, M.D. 004526393034 firstname.lastname@example.org|
|Principal Investigator: Nessn Azawi, Ph.D|