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

Recruiting

• Conditions: Liver Cirrhosis; Hepatocellular Carcinoma (HCC); Cholangiocarcinoma; Cholangitis, Sclerosing

• Registration Number: NCT06864195
• Lead Sponsor: Imperial College London

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-13
• Study First Submitted: 2025-02-20
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2027-01-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection	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.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom