Vitamin D & Immunity Study. Version 1.1

• Research type

  Research Study

• Full title

  Vitamin D & Immunity in Melanoma: a study of the role of vitamin D3 and inflammation in immune reactions to cancer cells

• IRAS ID

  129487

• Contact name

  Julia A Newton-Bishop

• Contact email

  j.a.newton-bishop@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Research summary

  Ulceration of the primary melanoma is a predictor of poor prognosis even at stage III melanoma (where metastasis has occurred to lymph nodes, sometimes years after resection of the primary).
  In previous studies our group has observed that tumour ulceration is associated with evidence of macrophage-driven inflammation and angiogenesis and that ulceration was more common in melanoma patients with a high body mass index (BMI). High BMI is in turn associated with increased cancer risk and reduced survival from cancer and this is hypothesised at least in part to result from the chronic inflammation which underlies the obesity related inflammation/metabolic syndrome. The analysis furthermore suggested that the association between high BMI and ulceration was diminished when the data were adjusted for serum level of vitamin D, suggesting that vitamin D might moderate chronic inflammation in the obesity related inflammation/metabolic syndrome.
  We have also observed that low vitamin D levels are associated with thicker (poorer prognosis) melanomas at diagnosis and with poorer survival.

  In this prospective case-control study we will compare circulating measures of chronic inflammation, and inflammation within resected tumours, in study participants with ulcerated tumours with corresponding measures in participants with non-ulcerated tumours to establish whether ulceration is associated with local and systemic inflammation.
  We will determine whether blood-derived measures of inflammation, evidence of inflammation in the resected tumour tissue and gene expression of circulating white blood cells are related to ulceration status and vitamin D levels at diagnosis (irrespective of ulceration status). We will then determine whether the measures of inflammation are decreased after vitamin D supplementation and what serum levels of vitamin D need to be reached before this is observed.

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  13/YH/0237

• Date of REC Opinion

  5 Aug 2013

• REC opinion

  Favourable Opinion