URINE-BASED DETECTION OF NON-MUSCLE INVASIVE BLADDER CANCER RECURRENCE
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|ClinicalTrials.gov Identifier: NCT03962933|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
|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 1. 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%) 9.
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|
|Estimated Study Start Date :||August 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962933
|Zealand University Hospital|
|Roskilde, Denmark, 4000|