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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-13

Study Completion Date

2027-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Liver Cirrhosis Hepatocellular Carcinoma (HCC) Cholangiocarcinoma Cholangitis, Sclerosing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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participants with liver cancer

Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma

No interventions assigned to this group

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

No interventions assigned to this group

healthy controls

Non-specific gastrointestinal symptoms, but a radiologically-normal liver

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes