title: Research protocol for a diagnostic study of non-invasive exhaled breath analysis for the prediction of oesophago-gastric cancer.
abstract: BACKGROUND
  Despite improvements in a range of chemo, radio and surgical therapies, the overall survival at 5 years from oesophago-gastric cancer remains poor and ranges from 10% to 30%. Early diagnosis is a key strategy to improve survival but early disease stage has non-specific symptoms that are very common while the warning clinical picture often indicates advanced disease. The aim of this research is to validate a breath test to predict oesophago-gastric cancer therefore allowing earlier diagnosis and introduction of treatment.
  
  
  METHODS
  The study will include 325 patients and be conducted across four major oesophago-gastric cancer centres in London, UK. This research will utilise selected ion flow-tube mass spectrometry (SIFT-MS) exhaled breath analysis, for comparison of predicted cancer risk based on the previously developed volatile organic compound exhaled breath model, with endoscopic findings and histology biopsies. This will determine the overall diagnostic accuracy for non-invasive breath testing for the diagnosis of oesophago-gastric cancer.
  
  
  BACKGROUND
  Approval was gained from NRES Committee London, on 16 July 2014 (REC reference 14/LO/1136) for the completion of this study. Different methods of dissemination will be employed including international clinical and patient group presentations, and publication of research outputs in a high-impact clinical journal. This is to ensure that the findings from this research will reach patients, primary care practitioners, scientists, hospital specialists in gastroenterology, oncology and surgery, health policymakers and commissioners as well as NHS regulatory bodies.
  
  
  BACKGROUND
  UKCRN18063; Pre-results.
authors.affiliation: Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Sheraz R
authors.initials: SR
authors.lastname: Markar
authors.affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Jesper
authors.initials: J
authors.lastname: Lagergren
authors.affiliation: Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: George B
authors.initials: GB
authors.lastname: Hanna
mesh_terms: D001944:Breath Tests / Q000379:methods*; D055088:Early Detection of Cancer / Q000379:methods*; D004938:Esophageal Neoplasms / Q000175:diagnosis*; D045853:Exhalation; D006801:Humans; D008131:London; D013274:Stomach Neoplasms / Q000175:diagnosis*
keywords: SURGERY