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Molecular signatures of radiosensitivity and IBTR in breast cancer

  • Research type

    Research Study

  • Full title

    Molecular signatures of radiosensitivity and ipsilateral breast tumour recurrence in breast cancer: A collaborative study between University of Edinburgh, NHS Scotland and PFS Genomics (Radiotype DX).

  • IRAS ID

    162496

  • Contact name

    Ian H Kunkler

  • Contact email

    iankunkler@yahoo.com

  • Sponsor organisation

    University of Edinburgh

  • Clinicaltrials.gov Identifier

    MREC number for PRIME I, /98/0/86; ISRCTN for PRIME I, 14817328; MREC number for Scottish Conservation Trial (SCT), SCT predated MREC (see Appendix 2, Section M)

  • Duration of Study in the UK

    1 years, 11 months, 28 days

  • Research summary

    At present radiotherapy (high energy treatment to destroy cancer cells) is given to the breast after breast conserving surgery in most women with early breast cancer. Breast conserving surgery tries to keep as much of the breast as possible. There is increasing interest in tailoring treatment to a molecular marker (fingerprint) of the individual patient's cancer. Currently there is no reliable molecular marker (fingerprint) which tells us which patients will respond to radiotherapy and which will not after breast conserving surgery. This proposal investigates whether the molecular marker of sensitivity to radiotherapy (called Radiotype DX) will identify breast cancer patients who are sensitive to a standard course of radiotherapy from those patients whose cancers are resistant to radiation. Those patients whose cancers are resistant to radiotherapy might benefit from more intensive local or anticancer drug treatment.

    We plan to collect tissue from the patient's original biopsy removed during surgery. We are also going to look at updated information from two historical clinical trials (Scottish Conservation Trial and PRIME I Trial) in which patients were allocated at random to breast conserving surgery alone or breast conserving surgery + whole breast radiotherapy. The Scottish Conservation and PRIME I trials were composed of 585 and 255 patients respectively. Anonymised tissues from these patients will be sent to a United States company (PFS Genomics) for extraction of RNA (ribonucleic acid). We will analyse whether the Radiotype DX molecular marker predicts which patients will develop a recurrence of the breast cancer in their breast. We will also update the long-term follow up of both trials for clinical outcomes.

  • REC name

    South East Scotland REC 01

  • REC reference

    16/SS/0090

  • Date of REC Opinion

    13 May 2016

  • REC opinion

    Further Information Favourable Opinion

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