Study Title: A prospective observational study to determine the negative predictive value of UroMark to rule out the presence of bladder cancer in patients with haematuria.
Short Title: DETECT I
DETECT I is a multicentre observational study to assess whether the test called UroMark can detect bladder cancer in patients who are being investigated for haematuria (blood in the urine). The test detects changes in the DNA of cells which are present in urine. Changes in DNA, called mutations or epigenetic alterations, are present in cells collected from a urine sample if cancer is present.
The study will recruit men and women who have been referred to hospital to have tests because of the finding of either visible or non-visible blood in the urine.
Everyone who agrees to take part will be receiving the normal investigations for haematuria in outpatient clinics. Subjects will be asked to provide three urine samples and complete a brief questionnaire.
Sponsor: University College London
Funder: Medical Research Council
ClinicalTrials.gov Identifier: NCT02676180