Status:
UNKNOWN
Assessment of BladderLight SurvEILlance
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Cytosystems Ltd
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 cance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT03427034
Start Date
February 1 2018
End Date
March 1 2020
Last Update
February 9 2018
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