Anticipate-X

  • Research type

    Research Study

  • Full title

    An observational multi-National study In Bladder Cancer Patients to detect recurrences After TURB Earlier with Xpert Bladder Cancer Monitor. EVALUATION OF THE XPERT® BLADDER CANCER MONITOR ASSAY COMPARED TO CYSTOSCOPY FOR THE FOLLOW-UP OF PATIENTS WITH HISTORY OF LOW OR INTERMEDIATE RISK NON-MUSCLE-INVASIVE BLADDER CANCER (NMIBC): AN OBSERVATIONAL PROSPECTIVE INTERNATIONAL MULTICENTER STUDY

  • IRAS ID

    234648

  • Contact name

    Hugh Mostafid

  • Contact email

    mostafid@me.com

  • Sponsor organisation

    CEPHEID EUROPE

  • Duration of Study in the UK

    1 years, 6 months, 1 days

  • Research summary

    Bladder cancer is the 5th most common cancer in Europe and has the highest recurrence rate of any malignancy. While the majority of patients with bladder cancer can be successfully treated with organ-sparing therapy, most will experience either a recurrence or progression. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment.
    Non-Muscle-Invasive Bladder Cancer (NMIBC) surveillance is based on cystoscopy and cytology. The first cystoscopy after Trans-Urethral Resection of the Bladder (TURB), or second-look TURB for high risk patients, is recommended 3 months after TURB for all tumours and a lifelong follow-up is thereafter recommended for intermediate and high risk tumours. Cytology sensitivity is lower for low grade than for high grade bladder cancers, for which it is considered a strong adjunct for surveillance. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance In that prospect, urinary molecular tests have been developed although none were deemed adequate in the EAU guidelines to replace cystoscopy.
    The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. It should be used in conjunction with other clinical measures to assess disease recurrence. The test provides a fast and accurate result, is non-invasive and easy to perform.
    The aim of this study is to test Xpert Bladder Cancer Monitor assay as a monitoring tool in the surveillance of low to intermediate risk TCC of the bladder.
    This study will assess the non-inferiority of Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk NMIBC.
    This is a multicenter, prospective study with 9 investigational sites in Europe.

  • REC name

    West Midlands - Solihull Research Ethics Committee

  • REC reference

    18/WM/0014

  • Date of REC Opinion

    26 Jan 2018

  • REC opinion

    Further Information Favourable Opinion