A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions (VOCAL2)

March 3, 2025 updated by: Imperial College London

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?

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Georgios Karagiannidis, MBBS(Hon)
Phone Number: +02075943396
Email: vocal-study@imperial.ac.uk

Study Locations

United Kingdom
- - London, United Kingdom
    - Recruiting
    - Imperial College London
    - Contact:
      
      Georgios Karagiannidis
      
      Phone Number: +02075943396
      
      Email: vocal-study@imperial.ac.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

People from secondary or tertiary centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
participants with liver cancer Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma
participants with benign liver disorders Liver cirrhosis, confirmed on imaging or histology from biopsy or Primary sclerosing cholangitis, confirmed on MRCP/ERCP or histology from biopsy
healthy controls Non-specific gastrointestinal symptoms, but a radiologically-normal liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

Principal Investigator: George Hanna, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)