Assessment of BladderLight SurvEILlance (ABSEIL)

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NHS Foundation Trust

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Bladder Cancer

Treatments

Device: BladderLight®

Study type

Interventional

Funder types

Other

Identifiers

NCT03427034
A094687

Details and patient eligibility

About

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

Full 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

Enrollment

2,100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

2,100 participants in 3 patient groups

Cystoscopic surveillance
Experimental group
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
Treatment:
Device: BladderLight®
Haematuria group
Experimental 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
Treatment:
Device: BladderLight®
Longitudinal group
No Intervention group
Description:
Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer.

Trial contacts and locations

0

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Central trial contact

kasra Paeb-Parsy, MBBS, FRCSEd

Data sourced from clinicaltrials.gov

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