An observational study in Liver Cirrhosis, Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Imperial College London · Observational
Liver cancer is often diagnosed too late for effective treatment. The VOCAL2 study is developing a simple, non-invasive breath test to help detect liver cancer earlier and monitor liver conditions like cirrhosis. The test analyzes tiny chemicals in exhaled breath called volatile organic compounds (VOCs) to identify signs of liver disease.
Who can take part?
Adults aged 18 or older who:
Have liver cancer (hepatocellular carcinoma or cholangiocarcinoma), or Have liver cirrhosis or primary sclerosing cholangitis, or Have tummy symptoms but a normal liver scan. What's involved?
Participants will:
Give a breath sample after fasting for 6 hours. Answer a few health questions. Allow access to relevant medical records. The appointment lasts about 1 hour at an NHS hospital. Benefits \& Risks
This research could lead to an earlier, easier way to detect liver cancer, but there's no direct health benefit for participants.
There are no risks, as breath sampling is completely non-invasive and safe. Where is the study happening? Led by Imperial College London, running in NHS hospitals across the UK.
Who is funding the study? The study is funded by Rosetrees and Stoneygate Trust.
Contact Information Email: vocal-study@imperial.ac.uk Phone: +44 (0)20 7594 3396
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 750 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
People from secondary or tertiary centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma
1. Liver cirrhosis, confirmed on imaging or histology from biopsy or 2. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy
Non-specific gastrointestinal symptoms, but a radiologically-normal liver
Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection
This outcome measures the ability of volatile organic compound (VOC) analysis in exhaled breath to accurately detect liver cancer. Breath samples will be analysed using thermal desorption gas chromatography-mass spectrometry (TD-GC-MS). The diagnostic accuracy will be determined by comparing VOC profiles with histological confirmation or radiological imaging as the reference standard. Sensitivity, specificity, and area under the receiver operating characteristic curve (AU-ROC) will be reported.
Time frame: Day 1
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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