Assessment of BladderLight SurvEILlance

Bladder Cancer Clinical Trial

— ABSEIL  

Official title:

Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03427034
• Other study ID #: A094687
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: January 30, 2018
• Last updated: February 2, 2018
• Start date: February 2018
• Est. completion date: March 2020

Study information

• Verified date: February 2018
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: kasra Paeb-Parsy, MBBS, FRCSEd
• Phone: +44(0)7769714323
• Email: kasra.saeb-parsy[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2100
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• BladderLight®
Using a cell collection device to look for the presence of bladder cancer cells

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Cytosystems Ltd

References & Publications (1)

Saeb-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To exclude presence of bladder cancer with sensitivity of 85%	In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.	12 month