DELIVER study Version 1.0

• Research type

  Research Study

• Full title

  A case control study in a population with clinical suspicion of liver cirrhosis to develop a risk model for the presence of cirrhosis using breath biomarkers/EVOC probes.

• IRAS ID

  342409

• Contact name

  Arun Shankar

• Contact email

  arun.shankar@nnuh.nhs.uk

• Sponsor organisation

  Owlstone Medical Ltd

• Duration of Study in the UK

  0 years, 10 months, 2 days

• Research summary

  The DELIVER-study aims to develop a breath test that can be used to identify subjects at risk of developing Liver Cirrhosis.

  Up to 75% of subjects with cirrhosis receive their first diagnosis after they present at the emergency services with late-stage liver disease. Detecting the disease earlier is difficult because early disease often has no symptoms. Earlier detection is also difficult as the current methods for diagnosis are either invasive or have limited diagnostic accuracy.

  Therefore, there is an unmet need for an easy to use, non-invasive point of care test that can help identify liver disease at earlier stages. A breath test may fulfil such requirements.
  
  In this study subjects will be asked to give a breath sample before and after ingesting a mixture of food grade products (called a probe). The study will enrol and compare subjects with cirrhosis against a control group of subjects with a clinical suspicion of cirrhosis.

  A probe is being given in this study as research has shown that cells inside the body produce substances that end up in the lungs and are breathed out. These studies have shown that those substances may be different if someone has a particular disease, including liver cirrhosis. Research has also shown that when we ingest a certain product it may be processed differently in the body if you are healthy, compared to if you have a particular disease. This difference in processing leads to different chemicals being released by the body which would show up on breath as a sign of the presence or absence of disease.

  The results from this study may give insight into the effectiveness of a breath test and provide data to develop a non-invasive test to aid earlier identification of liver cirrhosis that is widely available in primary care cents in the future.
  

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  24/WM/0116

• Date of REC Opinion

  5 Jun 2024

• REC opinion

  Further Information Favourable Opinion