Clinical trial NCT06864195: A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
Official title: Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Hepatocellular Carcinoma (HCC)
Cholangiocarcinoma
Cholangitis, Sclerosing
Keywords: breath
liver cancer
cirrhosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People from secondary or tertiary centers

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

Primary outcomes:
measure: Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: George Hanna
role: PRINCIPAL_INVESTIGATOR
References: