Assessment of BladderLight SurvEILlance

Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer

Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.

There are three arms to the proposed performance evaluation of the integrated test - arms 1 and 2 are cross-sectional studies examining the accuracy of the BladderLight® test in the detection of cancer of the urinary bladder in patients attending either Gross Haematuria clinic for a potential primary (first time) diagnosis (arm 1) or patients attending Cystsoscopic Surveillance clinic as follow up to a previous, treated case of bladder cancer (arm 2). Arm 3 is a longitudinal examination of disease state following a negative cystoscopy with a positive BladderLight® test - this will examine whether BladderLight® can predict progression to overt disease. Arm three will not involve any further requirement for physical sampling, but will involve result checking on subsequent cystoscopies

Inclusion Criteria:

1. Aged 18 years of age or above.
2. Patients attending Cystoscopic Surveillance clinic for monitoring of recurrence of urothelial carcinoma after having been treated for urothelial carcinoma / bladder cancer (Arm 1) OR Patients attending Gross Haematuria clinic (or equivalent) for cystoscopy/biopsy (if appropriate) relating to symptoms suggestive of possible urothelial cancer (Arm 2). Patients that will receive a cystoscopy as per standard practice.
3. Able to understand and sign the written Informed Consent Form.
4. Able and willing to follow the Protocol requirements

Exclusion Criteria:

1. Participation in any clinical study of an Investigational Medicinal Product during the 8 weeks preceding the sampling period of the study.
2. Patients that have a urinary tract stent, kidney stones or catheter