MAGIC Non-interventional Study

  • Research type

    Research Study

  • Full title

    Multicentre Assessment of G-CSF and dose Intensity of Chemotherapy (MAGIC) Non-interventional Study

  • IRAS ID

    341952

  • Contact name

    Daniel Rea

  • Contact email

    d.w.rea@bham.ac.uk

  • Sponsor organisation

    Accord Healthcare

  • Duration of Study in the UK

    0 years, 8 months, 26 days

  • Research summary

    Neutropenia(defined as an absolute neutrophil count [ANC] of <1.0 x109/L) is a potentially serious complication of chemotherapy, which can cause significant morbidity and mortality, result in dose delays and reductions, and can ultimately lead to reduced cancer survival.

    Granulocyte-colony stimulating factor (G-CSF) is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia (FN)Th in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

    Hence, the primary objective of this study is to provide real-world evidence on the use of granulocyte-colony stimulating factor (G-CSF) as primary prophylaxis for (neo)adjuvant chemotherapy in patients with primary breast cancer and its impact on relative dose intensity (RDI).

    This is a non-interventional study, designed to retrospectively extract data of patients with breast cancer who received G-CSF as primary prophylaxis for (neo)adjuvant chemotherapy as part of routine clinical practice within each participating hospital.

    There will be no direct patient contact with the study team throughout the research. However, the care team of patients meeting the inclusion criteria will contact patients to collect informed consent.

  • REC name

    Wales REC 6

  • REC reference

    24/WA/0246

  • Date of REC Opinion

    10 Sep 2024

  • REC opinion

    Further Information Favourable Opinion