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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Diagnostic test: Xpert® Bladder Cancer Detection Test

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.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Urology, Aarhus University Hopsital
• Greenland
  • Nuuk, Greenland, 3900
    • Queen Ingrid's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Greenlandic citizens aged 18 years and above, referred for cystoscopy; Patients who have been referred for a cystoscopy will be invited to participate in the study. During their cystoscopy appointment, they will be asked to provide a urine sample for the Xpert bladder cancer detection test.	Diagnostic test: Xpert® Bladder Cancer Detection Test; A urine sample is analyzed with the Xpert® Bladder Cancer Detection Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jørgen Bjerggaard Jensen
• Collaborators: Laborie Medical Technologies Inc.; Cepheid; Vingmed Danmark A/S; OneMed A/S
• Investigators: Principal Investigator: Nathalie D Fryd, MD, PhD student

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2023
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Bladder Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: GreenBladder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No