Assessment of BladderLight SurvEILlance

Phase 2

• Conditions: Bladder Cancer
• Interventions: Device: BladderLight®

• Registration Number: NCT03427034
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2018-01-30
• Status Verified: 2018-02
• Study Start: 2018-02
• Study First Submitted QC: 2018-02-02
• Last Update Submitted: 2018-02-02
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cystoscopic surveillance	BladderLight®	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
Haematuria group	BladderLight®	Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer

Primary Outcome Measures

Name	Time	Method
To exclude presence of bladder cancer with sensitivity of 85%	12 month	In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.