Bladder Cancer
Conditions
Keywords
Urine, Haematuria, Flexible cystoscopy, Recurrence, Cytology
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
Interventions
DEVICEBladderLight®
Using a cell collection device to look for the presence of bladder cancer cells
Sponsors
Cytosystems Ltd
Cambridge University Hospitals NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
all eligible patients will be recruited
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary Contactkasra Paeb-Parsy, MBBS, FRCSEd
Outcome results
None listed