ideasIdea
A urine DNA test to decide who with blood in the urine needs a camera test
Most people referred for blood in the urine do not have bladder cancer, yet all get cystoscopy. A urine DNA or methylation test could safely spare most of them.
Urinary methylation and mutation assays report high negative predictive value. Propose an RCT in the haematuria pathway: biomarker-negative patients randomised to deferred versus immediate cystoscopy, with missed muscle-invasive cancer as the safety endpoint and cystoscopies avoided as efficacy.
Hypothesis
Biomarker triage reduces cystoscopies by at least half with a missed high-grade cancer rate below 0.5%.
Rationale
Bladder cancer prevalence in haematuria referrals is 5-10%; cystoscopy capacity is a rate-limiting step for urology worldwide.
What would test it
Run a 3,000-patient RCT with a pre-agreed non-inferiority margin.
Maturity
early clinical
Who has to act
clinic
Cost to try
Medium ($1M to $50M)
Years to first evidence
3
Bottlenecks it attacks
- Most lethal cancers are found late · Screening exists for only a few cancers. Pancreatic, ovarian, liver, oesophageal and most lung cancers are found when cure is unlikely.
- Overdiagnosis and false alarms · Finding more cancer is not the same as saving lives. Screening also finds cancers that would never have hurt anyone, and treats them.