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Assessment of BladderLight SurvEILlance (ABSEIL)

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ClinicalTrials.gov Identifier: NCT03427034
Recruitment Status : Unknown
Verified February 2018 by Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Cytosystems Ltd
Information provided by (Responsible Party):
Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Cambridge University Hospitals NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: BladderLight® Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: all eligible patients will be recruited
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Cystoscopic surveillance
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
Device: BladderLight®
Using a cell collection device to look for the presence of bladder cancer cells

Experimental: Haematuria group
Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer
Device: BladderLight®
Using a cell collection device to look for the presence of bladder cancer cells

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



Primary Outcome Measures :
  1. To exclude presence of bladder cancer with sensitivity of 85% [ Time Frame: 12 month ]
    In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427034


Contacts
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Contact: kasra Paeb-Parsy, MBBS, FRCSEd +44(0)7769714323 kasra.saeb-parsy@nhs.net

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Cytosystems Ltd
Investigators
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Principal Investigator: kasra Saeb-Parsy, MBBS, FRCSEd Cambridge University Hospitals NHS Foundation Trust
Publications:
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Responsible Party: Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Consultant Urologist, Chief Investigator, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03427034    
Other Study ID Numbers: A094687
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be published in peer reviewed journals and presented at scientific meetings

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Cambridge University Hospitals NHS Foundation Trust:
Urine
Haematuria
Flexible cystoscopy
Recurrence
Cytology
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases