A Phase 2/3 interventional study of BladderLight® in Bladder Cancer, sponsored by Cambridge University Hospitals NHS Foundation Trust. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2/3, Interventional, and Diagnostic
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
Exclusion Criteria:
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®
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®
Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer.
Using a cell collection device to look for the presence of bladder cancer cells
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
No study locations are listed for this record.
Plan to share: Undecided — Data will be published in peer reviewed journals and presented at scientific meetings
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust