Assessment of BladderLight SurvEILlance

Cambridge University Hospitals NHS Foundation Trust2,100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,100

Conditions

Bladder Cancer

Interventions

BladderLight®DEVICE

Using a cell collection device to look for the presence of bladder cancer cells

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 month

Central Contacts

kasra Paeb-Parsy, MBBS, FRCSEd

CONTACT

+44(0)7769714323 kasra.saeb-parsy@nhs.net

Data from ClinicalTrials.gov

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