Status:
ACTIVE_NOT_RECRUITING
Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor
Lead Sponsor:
Jørgen Bjerggaard Jensen
Collaborating Sponsors:
Cepheid
Conditions:
Non-muscle Invasive Bladder Cancer
Urinary Biomarker
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to evaluate the potential clinical impact of a highly sensitive urinary marker, the Xpert Bladder Cancer Monitor, regarding possible reduction in number of flexible cystoscopies in an o...
Detailed Description
Epidemiology and treatment Bladder cancer is the 12th most diagnosed cancer worldwide with an incidence of approximately 550 000 new cases each year.1 A majority of the tumors are characterized as non...
Eligibility Criteria
Inclusion
- Age ≥18 years of age at the time of signing the Informed Consent Form
- Ability to understand the Participant Information sheet orally and in writing
- Signed Informed Consent Form
- Is, according to the investigator's judgement, able to comply with the trial protocol
- Previously diagnosed with high grade NMIBC Recurrence free at the time of inclusion detected by flexible cystoscopy
Exclusion
- History of any upper urinary tract tumor regardless of grade and stage within the last 5 years prior to randomization
- T1 tumor where re-resection has not been performed
- CIS or invasive tumor within 3 months before randomization
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT04100733
Start Date
November 1 2019
End Date
April 1 2027
Last Update
June 1 2023
Active Locations (3)
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1
Hospital of West Jutland
Holstebro, Danmark, Denmark, 7500
2
Aarhus University Hospital
Århus N, Denmark, 8200
3
Zealand University Hospital
Roskilde, Denmark