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Assessment of BladderLight SurvEILlance (ABSEIL)

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BladderLight®
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Urine, Haematuria, Flexible cystoscopy, Recurrence, Cytology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Cystoscopic surveillance

    Haematuria group

    Longitudinal group

    Arm 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

    Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer

    Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2018
    Last Updated
    February 2, 2018
    Sponsor
    Cambridge University Hospitals NHS Foundation Trust
    Collaborators
    Cytosystems Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03427034
    Brief Title
    Assessment of BladderLight SurvEILlance
    Acronym
    ABSEIL
    Official Title
    Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2018 (Anticipated)
    Primary Completion Date
    March 2020 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cambridge University Hospitals NHS Foundation Trust
    Collaborators
    Cytosystems Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer
    Keywords
    Urine, Haematuria, Flexible cystoscopy, Recurrence, Cytology

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    all eligible patients will be recruited
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cystoscopic surveillance
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Haematuria group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Longitudinal group
    Arm Type
    No Intervention
    Arm Description
    Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer.
    Intervention Type
    Device
    Intervention Name(s)
    BladderLight®
    Intervention Description
    Using a cell collection device to look for the presence of bladder cancer cells
    Primary Outcome Measure Information:
    Title
    To exclude presence of bladder cancer with sensitivity of 85%
    Description
    In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 years of age or above. 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. Able to understand and sign the written Informed Consent Form. Able and willing to follow the Protocol requirements Exclusion Criteria: Participation in any clinical study of an Investigational Medicinal Product during the 8 weeks preceding the sampling period of the study. Patients that have a urinary tract stent, kidney stones or catheter
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    kasra Paeb-Parsy, MBBS, FRCSEd
    Phone
    +44(0)7769714323
    Email
    kasra.saeb-parsy@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    kasra Saeb-Parsy, MBBS, FRCSEd
    Organizational Affiliation
    Cambridge University Hospitals NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data will be published in peer reviewed journals and presented at scientific meetings
    Citations:
    PubMed Identifier
    22968648
    Citation
    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.
    Results Reference
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    Assessment of BladderLight SurvEILlance

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