Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03427034
Status:
UNKNOWN
Last Update Posted:
2018-02-09
First Post:
2018-01-30
Brief Title:
Assessment of BladderLight SurvEILlance
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Determining the Specificity and Sensitivity of the BladderLight Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABSEIL
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None