Liver CirrhosisVOCAL2NCT06864195
A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
An observational study of Liver Cirrhosis and Hepatocellular Carcinoma (HCC), run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2025to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People from secondary or tertiary centers
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London
Georgios Karagiannidis, +02075943396, vocal-study@imperial.ac.uk
About this study
Official title: Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)
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?
Read more
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
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Cholangitis, Sclerosing
- Keywords
- breath, liver cancer, cirrhosis
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Cholangiocarcinoma, Cholangitis, Sclerosing, Liver Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| participants with liver cancer | Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma | |
| participants with benign liver disorders | 1. Liver cirrhosis, confirmed on imaging or histology from biopsy or 2. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy | |
| healthy controls | Non-specific gastrointestinal symptoms, but a radiologically-normal liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection
This outcome measures the ability of volatile organic compound (VOC) analysis in exhaled breath to accurately detect liver cancer. Breath samples will be analysed using thermal desorption gas chromatography-mass spectrometry (TD-GC-MS). The diagnostic accuracy will be determined by comparing VOC profiles with histological confirmation or radiological imaging as the reference standard. Sensitivity, specificity, and area under the receiver operating characteristic curve (AU-ROC) will be reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start13 Feb 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Hanna, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864195
- Sponsor's protocol ID
- 175288
- Acronym
- VOCAL2
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)
- ClinicalTrials.gov ID
- NCT06864195
- Acronym / sponsor ID
- VOCAL2 / 175288
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Cholangitis, Sclerosing
- Keywords
- breath, liver cancer, cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| participants with liver cancer | – | –Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma |
| participants with benign liver disorders | – | –1. Liver cirrhosis, confirmed on imaging or histology from biopsy or 2. Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy |
| healthy controls | – | –Non-specific gastrointestinal symptoms, but a radiologically-normal liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People from secondary or tertiary centers
Key inclusion criteria (7 listed)
- Males and females
- Adult participants ≥ 18 years old
- Participants with either:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection
Time frame: Day 1
This outcome measures the ability of volatile organic compound (VOC) analysis in exhaled breath to accurately detect liver cancer. Breath samples will be analysed using thermal desorption gas chromatography-mass spectrometry (TD-GC-MS). The diagnostic accuracy will be determined by comparing VOC profiles with histological confirmation or radiological imaging as the reference standard. Sensitivity, specificity, and area under the receiver operating characteristic curve (AU-ROC) will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Hanna principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Hepatocellular Carcinoma (HCC), run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Karagiannidis, MBBS(Hon) (+02075943396, vocal-study@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.