Clinical trial NCT06281691: GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit
Official title: GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Urinary Bladder Neoplasms
Keywords: Bladder Cancer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Cepheid
name: Laborie Medical Technologies Inc.
name: Vingmed Danmark A/S
name: OneMed A/S
First posted: 2024-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18 and above who reside in Greenland and are currently on the waiting list to undergo cystoscopy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Urology, Aarhus University Hopsital
city: Nuuk
country: Greenland
facility: Queen Ingrid's Hospital
Study officials:
affiliation: PhD student
name: Nathalie D Fryd, MD
role: PRINCIPAL_INVESTIGATOR
References: