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I-CARE - IBD Cancer and Serious Infections in Europe

  • Research type

    Research Study

  • Full title

    I-CARE - IBD Cancer and Serious Infections in Europe

  • IRAS ID

    177474

  • Contact name

    Shaji Sebastian

  • Contact email

    shaji.sebastian@hey.nhs.uk

  • Sponsor organisation

    GETAID

  • Clinicaltrials.gov Identifier

    NCT02377258, ClinicalTrials.gov Identifier

  • Duration of Study in the UK

    4 years, 0 months, 31 days

  • Research summary

    Inflammatory bowel disease (IBD), encompassing Crohn’s Disease (CD) and ulcerative Colitis (UC), is a chronic, disabling, incurable condition affecting 3 million Europeans. Current therapeutic options are limited immunosuppressant and biologics therapies such as anti-TNF therapy in IBD patients are now used both earlier in patient treatment journeys and in a larger proportion of IBD patients.
    Such treatments can reduce the need for major bowel surgery in many patients whose IBD cannot be brought into remission by less potent medications. However, anti-TNF treatments (Adalimumab, Infliximab, Vedolizumab) with or without additional immunosuppressive therapies such Azathiopurine, Mercaptapurine or Methotrexate, place patients at greater risk of developing cancer (particularly lymphoma). The extent to which this risk exists is not clearly defined because no large scale prospective cohort studies have been conducted.
    I-CARE is a European-wide, prospective, longitudinal, observational, multi-centre cohort study designed to answer the question of risk of developing cancer or serious infection in IBD patients using immunosuppressive and biologic therapies. A total of 16 countries will participate, including: Belgium, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, and UK.
    The study aims to recruit a total of 17,600 patients across Europe, of which 1,100 people will be recruited in UK. As an observational study there will no change to routine care for patients and the patients’ gastroenterologist can continue their regular care without affecting the study protocol. The only patient interventions will be annual e-questionnaires and monthly e-diaries used to record disease activity. Patients will be followed up for 3 years after recruitment and medical information about their disease status and demographic data will be collected from their medical notes. Potential patients will be identified by their Consultant Gastroenterologist based on their IBD diagnosis and medication regime at the time of consent.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    15/YH/0550

  • Date of REC Opinion

    18 Jan 2016

  • REC opinion

    Further Information Favourable Opinion