Urine-based Detection of Non-muscle Invasive Bladder
SOLUSION
1 other identifier
observational
196
1 country
1
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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJanuary 30, 2024
January 1, 2024
3.6 years
May 23, 2019
January 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrences rate
Recurrences rate
5 years
Study Arms (1)
Flexcystoscopy/Uromonitor
Control cystoscopy every 4 - 8 and 12 months as a standard procedure, And Urine test (Uromonitor) every 4 months
Eligibility Criteria
on-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%).
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nessn Azawilead
Study Sites (1)
Zealand University Hospital
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 24, 2019
Study Start
January 1, 2020
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
January 30, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share