Volatile Organic Compounds for Assessment of Liver Disease (VOCAL)
Research type
Research Study
Full title
Assessment of hepatobiliary disease through non-invasive detection of exhaled volatile organic compounds
IRAS ID
254249
Contact name
George Hanna
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Chronic liver disease has demonstrated a 400% increase in mortality rate since the 1970s in the UK. Insult to the liver from alcohol, fat deposition and viral infections amongst other causes results in inflammation and scarring of the liver. This is reversible in its early stages but can progress to permanent scarring (cirrhosis). Diagnosis of liver disease in the early stages is difficult: “liver function” blood tests often remain normal until disease is advanced. Those with cirrhosis have an up to 8% annual risk of developing liver cancer and screening for this involves burdensome 6 monthly ultrasounds and blood tests. Patients with cirrhosis are also at risk from transforming from a stable state into unstable states with significantly higher mortality in the latter group.
The aim of our study will be to determine the diagnostic accuracy of exhaled breath or urine for the prediction of liver scarring or liver cancer via detection of small molecules produced in the body (volatile organic compounds or VOCs) as well as establishing the VOC profile in patients with stable and unstable liver disease. Patients will be asked to breath directly into our sampling machine or a collection device and provide a urine sample. For patients attending outpatients regularly, we would aim to collect samples at each appointment so we can follow them up over a prolonged period of time. Collected samples will be analysed using mass spectrometry.
Breath testing could potentially be used in primary care as a non-invasive screening method for liver disease and liver cancer. It could trigger intervention at earlier, treatable disease stages. A breath test could be used to potentially identify those patients with chronic liver disease at a higher risk of becoming unstable.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0553
Date of REC Opinion
9 Oct 2019
REC opinion
Further Information Favourable Opinion