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Trial Title:
GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit
NCT ID:
NCT06281691
Condition:
Urinary Bladder Neoplasms
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Bladder Cancer
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Xpert® Bladder Cancer Detection Test
Description:
A urine sample is analyzed with the Xpert® Bladder Cancer Detection Test
Arm group label:
Greenlandic citizens aged 18 years and above, referred for cystoscopy
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.
Criteria for eligibility:
Study pop:
Individuals aged 18 and above who reside in Greenland and are currently on the waiting
list to undergo cystoscopy.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Urology, Aarhus University Hopsital
Address:
City:
Aarhus
Zip:
8000
Country:
Denmark
Facility:
Name:
Queen Ingrid's Hospital
Address:
City:
Nuuk
Zip:
3900
Country:
Greenland
Start date:
April 28, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Jørgen Bjerggaard Jensen
Agency class:
Other
Collaborator:
Agency:
Cepheid
Agency class:
Industry
Collaborator:
Agency:
Laborie Medical Technologies Inc.
Agency class:
Industry
Collaborator:
Agency:
Vingmed Danmark A/S
Agency class:
Other
Collaborator:
Agency:
OneMed A/S
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281691
