Department of Urology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK
Division of Clinical Medicine, University of Sheffield, Sheffield, UK.
BMJ Open. 2023 Sep 7;13(9):e076612. doi: 10.1136/bmjopen-2023-076612.
Around 25% of patients with bladder cancer (BCa) present with invasive disease. Non-randomised studies of population-based screening have suggested reductions in BCa-specific mortality are possible through earlier detection. The low prevalence of lethal disease in the general population means screening is not cost-effective and there is no consensus on the best strategy. Yorkshire has some of the highest mortality rates from BCa in England. We aim to test whether population screening in a region of high mortality risk will lead to a downward stage-migration of aggressive BCa, improved survival and is cost-effective.
YORKSURe is a tiered, randomised, multicohort study to test the feasibility of a large BCa screening randomised controlled trial. In three parallel cohorts, participants will self-test urine (at home) up to six times. Results are submitted via a mobile app or freephone. Those with a positive result will be invited for further investigation at community-based early detection clinics or within usual National Health Service (NHS) pathways. In Cohort 1, we will post self-testing kits to research engaged participants (n=2000) embedded within the Yorkshire Lung Screening Trial. In Cohort 2, we will post self-testing kits to 3000 invitees. Cohort 2 participants will be randomised between haematuria and glycosuria testing using a reveal/conceal design. In Cohort 3, we will post self-testing kits to 500 patients within the NHS pathway for investigation of haematuria. Our primary outcomes are rates of recruitment and randomisation, rates of positive test and acceptability of the design. The study is currently recruiting and scheduled to finish in June 2023.
The study has received the following approvals: London Riverside Research Ethics Committee (22/LO/0018) and Health Research Authority Confidentiality Advisory Group (20/CAG/0009). Results will be made available to providers and researchers via publicly accessible scientific journals.
ISRCTN34273159.
约 25%的膀胱癌（BCa）患者存在侵袭性疾病。基于人群的筛查的非随机研究表明，通过早期检测可能降低 BCa 特异性死亡率。普通人群中致命疾病的患病率较低意味着筛查没有成本效益，并且对于最佳策略尚无共识。约克郡是英格兰 BCa 死亡率最高的地区之一。我们旨在测试在高死亡率风险地区进行人群筛查是否会导致侵袭性 BCa 的分期向下迁移、提高生存率并具有成本效益。
YorkSURe 是一项分层、随机、多队列研究，旨在测试大规模 BCa 筛查随机对照试验的可行性。在三个平行队列中，参与者将在家中进行多达六次尿液自检。结果通过移动应用程序或免费电话提交。阳性结果的人将被邀请到社区早期检测诊所或常规国民保健服务（NHS）途径进行进一步检查。在队列 1 中，我们将向嵌入在约克郡肺癌筛查试验中的研究参与人员（n=2000）邮寄自检试剂盒。在队列 2 中，我们将向 3000 名受邀者邮寄自检试剂盒。队列 2 参与者将使用揭示/隐藏设计随机分为血尿和糖尿测试。在队列 3 中，我们将向 NHS 途径中接受血尿检查的 500 名患者邮寄自检试剂盒。我们的主要结果是招募和随机化率、阳性测试率和设计的可接受性。该研究正在招募中，计划于 2023 年 6 月结束。
该研究已获得以下批准：伦敦河滨研究伦理委员会（22/LO/0018）和健康研究管理局保密咨询小组（20/CAG/0009）。结果将通过公开获取的科学期刊提供给提供者和研究人员。
ISRCTN34273159。
