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

NCT06864195 | Recruiting

• 1 other identifier: 175288
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

breath; liver cancer; cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People from secondary or tertiary centers

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, United Kingdom

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Cholangiocarcinoma; Cholangitis, Sclerosing; Liver Neoplasms; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• George Hanna

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Karagiannidis, MBBS(Hon)

CONTACT

+02075943396; vocal-study@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 7, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)