Urinary Bladder Neoplasms
Conditions
Keywords
Bladder Cancer
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: The investigators hope to improve the current poor prognosis for bladder cancer patients in Greenland with the early detection. If this is successful, it could change the way patients are examined for bladder cancer in Greenland, but in the long term also in Denmark and other countries. Thus, the study will be able to determine whether a simple urine examination should be introduced early in the current cancer program in order to reduce the number of patients who need to undergo a cystoscopy and who can avoid this and get an earlier clarification.
Interventions
DIAGNOSTIC_TESTXpert® Bladder Cancer Detection Test
A urine sample is analyzed with the Xpert® Bladder Cancer Detection Test
Sponsors
Jørgen Bjerggaard Jensen
Cepheid
Laborie Medical Technologies Inc.
Vingmed Danmark A/S
OneMed A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation | 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 |
Countries
Denmark, Greenland
Contacts
PRINCIPAL_INVESTIGATORNathalie D Fryd, MD
PhD student
Outcome results
None listed