UnknownPhase 2/3

Assessment of BladderLight SurvEILlance

2,100 participantsStarted 2018-02

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

To exclude presence of bladder cancer with sensitivity of 85%

Timeframe: 12 month

NCT IDNCT03427034

SponsorCambridge University Hospitals NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03

kasra Paeb-Parsy, MBBS, FRCSEd