Urothelial cancer diagnosis and surveillance using urine DNA testing: a randomized clinical trial

Cancers of the bladder and upper urinary tract are diagnosed in 600 000 people annually worldwide. Their most common symptom is blood in urine, triggering an examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year, but only 10% result in cancer diagnosis. After a cystoscopy, patients suffer from discomfort and elevated urination frequency for a few days, with a 3% risk of urinary tract infection. A minimally invasive test that distinguishes between cancer positive and negative patients could significantly improve patient quality of life. We have developed an at-home urine collection kit and laboratory DNA test that can detect bladder cancer at 98% sensitivity. In this project we initiate two randomized clinical trials to investigate whether urine DNA testing can safely and cost-effectively replace most cystoscopies in the diagnostic and post-operative surveillance settings.