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NCT06281691 Clinical Trial

GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit

Urinary Bladder Neoplasms Clinical Trial

Official title:
GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06281691
Other study ID # GreenBladder
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 28, 2023
Est. completion date November 30, 2025

Study information
Verified date February 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 150
Est. completion date November 30, 2025
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Xpert® Bladder Cancer Detection Test
A urine sample is analyzed with the Xpert® Bladder Cancer Detection Test

Locations
Country Name City State
Denmark Department of Urology, Aarhus University Hopsital Aarhus
Greenland Queen Ingrid's Hospital Nuuk

Sponsors (5)
Lead Sponsor Collaborator
Jørgen Bjerggaard Jensen Cepheid, Laborie Medical Technologies Inc., OneMed A/S, Vingmed Danmark A/S

Countries where clinical trial is conducted

Denmark,  Greenland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation 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 Baseline
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