A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
Observational · No treatment assigned · 1 site · Imperial College London
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Liver Cirrhosis, Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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)
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 750 participants are expected to take part.
- The study has 3 groups.
- Start date: 2025-02-13.
- Main results expected around 2027-01-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Groups in this study
- participants with liver cancer
- participants with benign liver disorders
- healthy controls
Main thing being measured
- Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection (Day 1)
In the researchers’ words
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.
Words you might see
- MRCP: an MRI scan of the bile ducts and pancreas.
- ERCP: a procedure using a scope and dye to look at (and sometimes treat) the bile ducts.
- Cirrhosis: advanced scarring of the liver.
- Cholangiocarcinoma: cancer of the bile ducts.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Liver Cirrhosis; Hepatocellular Carcinoma (HCC); Cholangiocarcinoma; Cholangitis, Sclerosing |
| Lead sponsor | Imperial College London |
| Enrollment | 750 (estimated) |
| Start date | 2025-02-13 |
| Primary completion (est.) | 2027-01-31 |
| First posted | 2025-03-07 |
| Last updated | 2025-03-07 |
| Official title | Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2) |
| ClinicalTrials.gov ID | NCT06864195 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College London | London | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.