This is a prospective multicentre observational study to assess the sensitivity of the
UroMark assay to detect bladder cancer in participants with new or recurrent disease. The
study will recruit patients with newly detected or recurrent bladder cancer. The reference
standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade
1, 2 or 3 diseases with or without CIS, or CIS alone.
Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached
and asked to consent for this study. Consenting participants will be provided with a urine
sample collection kit and asked to provide a urine sample. Samples can be provided at home
and posted to the receiving lab using the stamped addressed envelope. The urine sample must
be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance
cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.
The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study
requiring provision of a urine sample, it will be possible for patients in DETECT II to be
recruited to other trials.