NCT06864195Recruiting
A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)
Source: ClinicalTrials.gov · Last updated 7 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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: Phone: +44 (0)20 7594 3396
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 13 Feb 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Imperial College London
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06864195
What you commit to
- Study type: Observational
- Planned participants: 750
- From 13 Feb 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active infection, or receiving immunosuppressive medications, within the preceding eight weeks
- Previous liver resection
- Already received chemotherapy, radiotherapy or surgery for their liver cancer
Other illness
- History of another cancer within the previous five years
Other
- Comorbidities preventing breath collection
- Pregnant women (checked verbally with participant).
- Unable to provide informed written consent
Who the study is looking for
- Males and females
- Adult participants ≥ 18 years old
- Participants with either:
- Histologically or radiologically-confirmed\* hepatocellular carcinoma or cholangiocarcinoma (participants with liver cancer)
- Liver cirrhosis, confirmed on imaging or histology from biopsy (participants with benign liver disorders)
- Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy (participants with benign liver disorders)
- Non-specific gastrointestinal symptoms, but a radiologically-normal liver (healthy controls)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.