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OpenTrials
Completed

NCT Number: NCT06281691

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, Aarhus University Hopsital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xpert® Bladder Cancer Detection Test

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Jørgen Bjerggaard Jensen

Other

Collaborators

  • Cepheid
  • Laborie Medical Technologies Inc.
  • OneMed A/S
  • Vingmed Danmark A/S

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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