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

NCT06281691 | Completed

• 1 other identifier: GreenBladder
• Study Type: observational
• Target: 127
• Locations: 2 countries
• Sites: 2

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.

Conditions

Urinary Bladder Neoplasms

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Xpert® Bladder Cancer Detection Test DIAGNOSTIC_TEST

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

Greenlandic citizens aged 18 years and above, referred for cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients not willing to participate.

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead
• Cepheid: collaborator
• Laborie Medical Technologies Inc.: collaborator
• Vingmed Danmark A/S: collaborator
• OneMed A/S: collaborator

Study Sites (2)

Department of Urology, Aarhus University Hopsital

Aarhus, 8000, Denmark

Location

Queen Ingrid's Hospital

Nuuk, 3900, Greenland

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Nathalie D Fryd, MD

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 28, 2024
• Study Start: December 28, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); GR (1)