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DETECT II: To Detect the Sensitivity of the UroMark Assay

Sponsor
University College, London (Other)
Overall Status
Unknown status
CT.gov ID
NCT02781428
Collaborator
(none)
1,643
Enrollment
19
Locations
47.2
Anticipated Duration (Months)
86.5
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective multicentre observational study to assess the sensitivity of the UroMark assay to detect bladder cancer in participants with new or recurrent disease. The study will recruit patients with newly detected or recurrent bladder cancer. The reference standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade 1, 2 or 3 diseases with or without CIS, or CIS alone.

Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached and asked to consent for this study. Consenting participants will be provided with a urine sample collection kit and asked to provide a urine sample. Samples can be provided at home and posted to the receiving lab using the stamped addressed envelope. The urine sample must be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.

The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study requiring provision of a urine sample, it will be possible for patients in DETECT II to be recruited to other trials.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is an observational study and participants will receive the standard of care according to local MDT guidelines for the treatment and surveillance of bladder cancer. As the study involves collection of a urine sample, subjects are permitted to be entered into other trials. The DETECT II study will recruit patients with newly diagnosed and recurrent bladder cancer. As this study is only observational and no intervention is trial related the patients will be given minimum 24 hours to consider this study and decide to take part as they will be approached in clinic at first instance. Due to the initial urine sample being required before any standard of care is received they will be consented within 24 hours of being informed of the study. Most newly diagnosed bladder cancers are detected in patients being investigated for haematuria and attending a haematuria clinic. Most recurrent bladder cancers are detected by cystoscopy at bladder cancer check cystoscopy clinics.

    Patients with a visual diagnosis or new or recurrent bladder cancer will be eligible for the DETECT II study. The baseline UroMark urine collection will be collected once the visual diagnosis of bladder cancer is established. The UroMark sample must be provided before TURBT in all cases.

    Patients will be approached following cystoscopy and asked to consent to study entry. The DETECT II study will involve obtaining a voided urine sample. Patients will be given a UroMark urine sample kit and asked to provide the urine sample at home and post the sample to the receiving lab using the stamped addressed envelope.

    Patients will receive the standard tests and investigations for bladder cancer. The standard treatment for bladder cancer is summarised as:

    • TURBT following which it is recommended that patients with NMIBC receive a single instillation of chemotherapy unless contraindicated.

    • Intermediate risk NMIBC will be considered for a 6 week inductive course of intravesical chemotherapy after TURBT.

    • High risk NMIBC may require a second TURBT called re-resection TURBT, usually within 6 weeks of the first. The re--resection or second TURBT is performed for pathological stage pT1 tumours to exclude residual detrusor muscle invasion (stage pT2 at least).

    There are 2 treatment choices when the high risk status has been confirmed clinically:

    • A course of inductive followed by maintenance intravesical BCG

    • An operation to remove the bladder (a cystectomy).

    • Cystectomy or radiotherapy are the options for patients diagnosed with MIBC

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1643 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Multicentre Observational Study Design to Determine the Sensitivity of the UroMark Assay, a Urine Test, to Detect New and Recurrent Low, Intermediate and High Grade Bladder Cancer
    Actual Study Start Date :
    Sep 26, 2016
    Anticipated Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Sep 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. The sensitivity of the UroMark assay to detect bladder cancer for grades 1-3, stage Ta -T4 [2 years]

    Secondary Outcome Measures

    1. The ability of the UroMark assay to detect the recurrence in NMIBC in patients undergoing cystoscopic surveillance for bladder cancer [2 years]

    2. A comparison between UroMark and other control assays including molecular tests [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must be over 18 years of age.

    • Visual diagnosis or suspected diagnosis of bladder cancer following cystoscopy.

    • Able to give informed written consent to participate

    Exclusion Criteria:

    • Unwilling to undergo TURBT

    • Unable to give informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tameside General Hospital Ashton-under-Lyne United Kingdom
    2 East Lancashire Hospitals NHS Trust Blackburn United Kingdom
    3 Royal Bolton Hospital Bolton United Kingdom
    4 The Pennine Acute Hospitals NHS Trust Bury United Kingdom
    5 University Hospital Coventry Coventry United Kingdom
    6 Medway Maritime Hospital Gillingham United Kingdom
    7 university College London Hospital London United Kingdom W1G 8PH
    8 Royal Free London NHS Foundation Trust London United Kingdom
    9 Macclesfield Hospital Macclesfield United Kingdom
    10 Norfolk & Norwich University Hospital Norwich United Kingdom
    11 King's Mill Hospital Nottingham United Kingdom
    12 East Surrey Hospital Redhill United Kingdom
    13 Northern Lincolnshire & Goole NHS Foundation Trust Scunthorpe United Kingdom
    14 Western Sussex Hospitals NHS Foundation Trust Shoreham-by-Sea United Kingdom
    15 Royal Shrewsbury Hospital Shrewsbury United Kingdom
    16 Stepping Hill Hospital Stockport United Kingdom
    17 University Hospital of North Tees Stockton-on-Tees United Kingdom
    18 Royal Albert Edward Infirmary Wigan United Kingdom
    19 New Cross Hospital Wolverhampton United Kingdom

    Sponsors and Collaborators

    • University College, London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT02781428
    Other Study ID Numbers:
    • 16/0226
    First Posted:
    May 24, 2016
    Last Update Posted:
    Oct 9, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Oct 9, 2019