Non-invasive breath testing to detect colorectal cancer: protocol for a multicentre, case-control development and validation study (COBRA2 study).

Journal: BMC cancer
Published Date: Jul 29, 2025

Abstract

BACKGROUND: Colorectal cancer (CRC) is the fourth most common cancer in the United Kingdom. The five-year survival rate from CRC is only 10% when discovered at a late stage, but can exceed 90% if diagnosed early. Symptoms related to CRC can be non-specific, and therefore the decision to refer for a colonoscopy can be challenging. Breath analysis potentially offers a simple and quick method to detect CRC specific volatile organic compounds (VOCs) in breath. This protocol describes the COBRA2 study which aims to develop and validate the clinical prediction model (CPM) in the detection of CRC based on the breath test. An exploratory comparison between the breath test and faecal immunochemical test (FIT) will also be carried out to assess whether combining both tests improves diagnostic performance.

Authors

  • Michael G Fadel
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • James Murray
    Human Performance Research Centre, School of Sport, Exercise and Rehabilitation, Faculty of Health, University of Technology Sydney (UTS), Moore Park, Sydney, NSW, Australia.
  • Georgia Woodfield
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Ilaria Belluomo
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Ivan Laponogov
    Computational and Systems Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.
  • Aaron Parker
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Valerio Converso
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • James K Ellis
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Pete Wheatstone
    Patient and Public Involvement, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
  • Julie Hepburn
    Patient and Public Involvement, Health and Care Research Wales Support Centre, Cardiff, UK.
  • Chris Groves
    Department of Gastroenterology, St George's Hospital, London, UK.
  • Kevin Monahan
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Brian P Saunders
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Patrik Španěl
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Kirill Veselkov
    Computational and Systems Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.
  • Amanda J Cross
    Department of Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London, W12 0NN, UK.
  • Christos Kontovounisios
    Department of Surgery and Cancer, Imperial College London, London, United Kingdom.
  • Linda D Sharples
    Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • George B Hanna
    Department of Surgery and Cancer, Imperial College London, United Kingdom.

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