Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor
Who is this study for? Adult patients with recurrence-free, high-grade Non-Muscle Invasive Bladder Cancer
What treatments are being studied? Xpert Bladder Cancer Monitor
Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 outpatient setting without decreasing recurrence-free survival or increasing risk of progression.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Aarhus University Hospital
Århus N
Hospital of West Jutland
Holstebro
Zealand University Hospital
Roskilde
Time Frame
Start Date: 2019-11-01
Completion Date: 2027-04
Participants
Target number of participants: 392
Treatments
Active_comparator: Control
Study subjects will cohere to current clinical guidelines for follow-up regimes of HG NMIBC with flexible cystoscopy and cytology every four months for a period of two years.
Experimental: Intervention
Patients in the interventional arm will be followed at 4, 8, 16 and 20 months after inclusion with Xpert Bladder Cancer Monitor-test (and urinary cytology) instead of flexible cystoscopy.
Related Therapeutic Areas
Sponsors
Leads: Jørgen Bjerggaard Jensen
Collaborators: Cepheid