A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females
Adult participants ≥ 18 years old
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)
Disqualifiers
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
Trial population
People from secondary or tertiary centers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
750 Participants
are grouped into 3 trial groupsGroup A: participants with liver cancer
Group B: participants with benign liver disorders
Group C: healthy controls
Trial outcomes
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.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov