Clinical trial · Interventional
Assessment of BladderLight SurvEILlance
Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
NCT03427034CI-TRIAL-00031616ABSEILunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BladderLight® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cystoscopic surveillance
- description
- 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
- interventionNames
- Device: BladderLight®
- type
- EXPERIMENTAL
- label
- Haematuria group
- description
- Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer
- interventionNames
- Device: BladderLight®
- type
- NO_INTERVENTION
- label
- Longitudinal group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDSaeb-Parsy K, Wilson A, Scarpini C, Corcoran M, Chilcott S, McKean M, Thottakam B, Rai B, Nabi G, Rana D, Perera M, Stewart K, Laskey RA, Neal DE, Coleman N. Diagnosis of bladder cancer by immunocytochemical detection of minichromosome maintenance protein-2 in cells retrieved from urine. Br J Cancer. 2012 Oct 9;107(8):1384-91. doi: 10.1038/bjc.2012.381. Epub 2012 Sep 11. PMID 22968648