Recruiting

NCT Number: NCT06864195

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

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: [email protected] Phone: +44 (0)20 7594 3396

Recruiting

Interested in participating?

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Key information

Conditions

Liver Cirrhosis Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Cholangitis Cholangitis, Sclerosing Digestive System Diseases Digestive System Neoplasms Fibrosis Hepatocellular Carcinoma (HCC) Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College London

London, United Kingdom

Location status: Recruiting

Location contact

Georgios Karagiannidis

CONTACT

[email protected]

+02075943396

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

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

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Karagiannidis, MBBS(Hon)

CONTACT

[email protected]

+02075943396

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2)

Acronym: VOCAL2

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 7, 2025
Registry last updated: Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed