GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •Patients not willing to participate.
研究组 & 干预措施
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.
干预措施: Xpert® Bladder Cancer Detection Test (Diagnostic Test)
结局指标
主要结局
Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation
时间窗: 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
次要结局
未报告次要终点
研究者
Jørgen Bjerggaard Jensen
Professor
Aarhus University Hospital