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PRECISION: PREvent ductal Carcinoma In Situ Invasive Overtreatment Now

  • Research type

    Research Study

  • Full title

    PRECISION: PREvent ductal Carcinoma In Situ Invasive Overtreatment Now

  • IRAS ID

    247823

  • Contact name

    Elinor Sawyer

  • Contact email

    elinor.sawyer@kcl.ac.uk

  • Sponsor organisation

    Public Health England

  • Duration of Study in the UK

    4 years, 11 months, 30 days

  • Research summary

    Ductal carcinoma in situ (DCIS) accounts for 25% of all ‘breast cancers’ detected. DCIS is usually treated by surgery, radiotherapy and endocrine therapies with the associated consequences of treatment. However, there is no evidence that treating low and intermediate grade DCIS is needed to save lives.

    PRECISION is an international collaboration building on multiple studies conducted in the UK, Europe and the US over the last two decades. It aims reduce the burden of DCIS overtreatment through the development of tests to support decision-making by clinicians, without compromising the excellent outcomes for DCIS presently achieved.

    The Sloane Audit is a UK wide prospective audit of screen detected harmless cancers and precancerous conditions of the breast, and is part of Public Health England’s (PHE's) Screening Quality Assurance Service (SQAS). PRECISION will use a range of established and innovative laboratory methods applied to DCIS pathology sample sourced from the Sloane Audit to identify and validate features distinguishing aggressive from harmless DCIS.

    Samples and data from three groups will be collected to enable in depth molecular studies. Extensive genomic study and imaging analysis will be performed. Studies will be performed to study the biology of DCIS in detail, and the results will be incorporated into a clinical risk prediction model.

    This application relates to work package one of the PRECISION study. The application is for ethical approval for the release of clinical data held by the Sloane Audit. This data will be released in an anonymised format to the Netherlands Cancer Institute (NKI)under a data sharing contract with Public Health England (PHE).

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    18/WM/0400

  • Date of REC Opinion

    14 Dec 2018

  • REC opinion

    Favourable Opinion