GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 127
- Locations
- 2
- Primary Endpoint
- Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation
Study Overview
Brief Summary
The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland.
Detailed Description
Methods:
Citizens of Greenland above the age of 18 years referred for cystoscopy will be invited to participate in an observational study at the time of already planned cystoscopy.
Hypothesis:
The investigators hypothesize that the Xpert® Bladder Cancer Detection test can identify patients with a bladder tumor and serve as a future selection tool to support clinical decision whether to perform a cystoscopy or not - especially in areas with limited access to urological services.
Perspectives:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age at the time of signing the Informed Consent Form with an indication for cystoscopy and planned for this already at study inclusion.
- •Ability to understand the Participant Information Sheet orally and in writing in either Danish or Greenlandic.
- •Signed Informed Consent Form.
- •Is, according to the Investigator's judgement, able to comply with the trial protocol.
Exclusion Criteria
- •Patients not willing to participate.
Arms & Interventions
Greenlandic citizens aged 18 years and above, referred for cystoscopy
Patients who have been referred for a cystoscopy will be invited to participate in the study. During their cystoscopy appointment, they will be asked to provide a urine sample for the Xpert bladder cancer detection test.
Intervention: Xpert® Bladder Cancer Detection Test (Diagnostic Test)
Outcomes
Primary Outcomes
Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation
Time Frame: Baseline
To assess the reliability and precision of Xpert Bladder Cancer Detection test ability to correctly identify cases of bladder cancer in patients as part of the diagnostic investigation
Secondary Outcomes
No secondary outcomes reported
Investigators
Jørgen Bjerggaard Jensen
Professor
Aarhus University Hospital