Assessment of BladderLight SurvEILlance

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

Detailed Description
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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

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: BladderLight®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years of age or above. 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. Able to understand and sign the written Informed Consent Form. Able and willing to follow the Protocol requirements Exclusion Criteria: Participation in any clinical study of an Investigational Medicinal Product during the 8 weeks preceding the sampling period of the study. Patients that have a urinary tract stent, kidney stones or catheter

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: all eligible patients will be recruited
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystoscopic surveillance<br>Patients with previous history of bladder cancer undergoing flexible cystoscopy will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer | Device: BladderLight®<br>* Using a cell collection device to look for the presence of bladder cancer cells<br>|
| Experimental: Haematuria group<br>Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer | Device: BladderLight®<br>* Using a cell collection device to look for the presence of bladder cancer cells<br>|
| No Intervention: Longitudinal group<br>Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To exclude presence of bladder cancer with sensitivity of 85% | In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urine, Haematuria, Flexible cystoscopy, Recurrence, Cytology