Diet and/or clinical interventions on biomarkers in NET and Controls

• Research type

  Research Study

• Full title

  Effect of diet and/or routinely used clinical interventions on biomarkers in blood and urine in patients with neuroendocrine tumours (NETs) and controls

• IRAS ID

  191832

• Contact name

  Martin O.Weickert

• Contact email

  martin.weickert@uhcw.nhs.uk

• Sponsor organisation

  University Hospitals Coventry & Warwickshire NHS Trust

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  The Arden Neuroendocrine Tumour (NET) Centre in University Hospitals Coventry & Warwickshire (UHCW) NHS Trust is one of eight European Neuroendocrine Tumor Society (ENETS) Centres of Excellence (CoE) in the UK. NET related research is an integral part for successful re audit of ENETS CoE status, as scheduled for February 2018.

  Our objective is to investigate the effect of diet and nutrition on diagnostic and therapeutic aspects in patients with NET.
  Prospective observational study: all patients with NET who agree to provide blood (5-10 mL) and urine samples (20 mL) every 6-12 month (usually sampled together with routinely required blood and urine tests)

  Nutritional intervention: 50 – 75 patients with NET and 20 – 30 controls without a diagnosis of NET
  Nutritional intervention: 3 visits after 10-h overnight fasts; first visit: IV cannula; breakfast and beverages delayed for 180 min, blood sampling every 30 min for 180 min; second visit: IV cannula, breakfast delayed for 180 minutes, but consumption of tea/coffee encouraged, blood sampling every 30 min for 180 min; third visit: IV cannula, 5-item breakfast together with tea/coffee, blood sampling every 30 min for 180 min. Plasma/serum and urine samples will be collected during all the visits after dietary precautions (that are known to confound with the results of urine and serum biomarkers for NET). Urine samples will be also sampled upon arrival of the participant and after the 180 min study period..
  Subjects with known NET will be recruited
  Main inclusion criteria: age 18 – 80 years, both genders, signed informed consent. Histologically confirmed diagnosis of NET
  Main exclusion criteria: Pregnancy. Unwell patients n/a
  Provision of breakfast and tea/coffee
  Enhanced understanding to assess the effects of diet and/or routinely used clinical interventions on routine clinical markers (body weight, blood pressure, postural hypotension, heart rate) and biomarkers in blood and urine in patients with NET and controls

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  15/EM/0527

• Date of REC Opinion

  25 Nov 2015

• REC opinion

  Unfavourable Opinion