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A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions

Sponsor: Imperial College London

NCT ID: NCT06864195

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
750
Started
2025-02-13
Last checked
2025-03

Plain English Summary

What is this study?

  • • Testing a new treatment for liver cirrhosis
  • • Clinical study - 750 participants
  • • Liver cancer is often diagnosed too late for effective treatment

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with liver cirrhosis

Where?

  • • London - Imperial College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Liver CirrhosisHepatocellular Carcinoma (HCC)CholangiocarcinomaCholangitis, Sclerosing

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What 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...
  • ✓Liver cirrhosis, confirmed on imaging or histology from biopsy (participants with benign liver disorders)

Who cannot take part

  • ✗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 drug treatment, radiotherapy or surgery for their liver cancer
  • ✗other health conditions preventing breath collection
See the full 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 Is This Study? (1 UK site)

Imperial College London

London, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Georgios Karagiannidis, MBBS(Hon)

Sponsor contact

CONTACT

+02075943396 vocal-study@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-03