NCT06864195 A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
| NCT ID | NCT06864195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2025-02-13 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
George Hanna
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT06864195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864195 currently recruiting?
Yes, NCT06864195 is actively recruiting participants. Contact the research team at vocal-study@imperial.ac.uk for enrollment information.
Where is the NCT06864195 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06864195 clinical trial?
NCT06864195 is sponsored by Imperial College London. The principal investigator is George Hanna at Imperial College London. The trial plans to enroll 750 participants.