A breath test to detect liver cancer and monitor liver health
Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)
This study is testing a new breath test to see if it can help find liver cancer earlier and keep track of liver health in adults with liver issues or certain stomach symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT06864195 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a non-invasive breath test that analyzes volatile organic compounds (VOCs) in exhaled breath to detect liver cancer earlier and monitor liver conditions such as cirrhosis. Participants will provide a breath sample after fasting for six hours and answer health-related questions, with the entire appointment lasting about one hour at an NHS hospital. The study focuses on adults with liver cancer, cirrhosis, or specific gastrointestinal symptoms but normal liver scans.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with liver cancer, liver cirrhosis, primary sclerosing cholangitis, or non-specific gastrointestinal symptoms with a normal liver scan.
Not a fit: Patients with active infections, recent cancer history, or those unable to provide breath samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could enable earlier detection of liver cancer, potentially improving treatment outcomes.
How similar studies have performed: While the approach of using breath analysis for cancer detection is innovative, similar studies have shown promise in other cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females * Adult participants ≥ 18 years old * Participants with either: 1. Histologically or radiologically-confirmed\* hepatocellular carcinoma or cholangiocarcinoma (participants with liver cancer) 2. Liver cirrhosis, confirmed on imaging or histology from biopsy (participants with benign liver disorders) 3. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy (participants with benign liver disorders) 4. Non-specific gastrointestinal symptoms, but a radiologically-normal liver (healthy controls) Exclusion Criteria: * Active infection, or receiving immunosuppressive medications, within the preceding eight weeks * History of another cancer within the previous five years * Previous liver resection * Already received chemotherapy, radiotherapy or surgery for their liver cancer * Comorbidities preventing breath collection * Pregnant women (checked verbally with participant). * Unable to provide informed written consent
Where this trial is running
London
- Imperial College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: George Hanna — Imperial College London
- Study coordinator: Georgios Karagiannidis, MBBS(Hon)
- Email: vocal-study@imperial.ac.uk
- Phone: +02075943396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.