|The primary objective of the study is to investigate the ability of the UroMark, a urinary based test, to detect bladder cancers across a spectrum of stage and grade of disease. The secondary objective is the determine if UroMark can detect tumour recurrence during the surveillance period after transurethral resection of bladder tumour (TURBT). A qualitative assessment to understand patient acceptance of a urinary based biomarker as an alternative or combined with cystoscopy (direct inspection of the bladder) in cohort of patients undergoing surveillance cystoscopy will also be performed. The UroMark is currently undergoing late phase validation and will analyse DNA from cells present in urine.
Men and women ≥18 years who have a cystoscopic confirmation of bladder tumour will be recruited into the trial. The subjects will be consented to provide a control urine sample in clinic, which is part of standard of care, as well as urine sample collected at home using a UroMark kit which will be posted to the laboratory. A home urine sample will also be collected prior to each surveillance cystoscopy which will be performed in accordance to NICE guidance.
Subjects will also complete a questionnaire. Patients will be followed-up for 24 months.
This study is a prospective observational study without any intervention. It is expected that there will be minimal ethical, legal or management issues. Lay-persons who are typical of the subjects who might be recruited have been consulted in developing this proposal.
Home urine collection is straight forward. Urine collection can be performed at anytime. The questionnaire will be straight forward.
Prospective subjects will be identified from flexible cystoscopy clinics or pre-assessment clinics for patients going to have a transurethral resection of bladder tumour (TURBT). A clinician can obtain verbal consent from the subject which will be documented in the medical notes. Written consent can be obtained at a later stage if the subject is happy to
participate. Home urine collection can be posted back to the receiving laboratory. Subjects will be contacted at 3 monthly intervals for 24 months to inform them that a UroMark kit will be posted to them for them to send back for urine collection.
With respect to confidentiality, we will follow the ‘Caldicott Principles’ as implemented by UCL (study sponsor).