Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06864195

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

Led by Imperial College London · Updated on 2025-03-07

750

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new, simple breath test that analyzes volatile organic compounds (VOCs) in exhaled breath to help detect liver cancer earlier and monitor liver conditions such as cirrhosis and primary sclerosing cholangitis. This study focuses on adults aged 18 and older who have liver cancer, liver cirrhosis, primary sclerosing cholangitis, or tummy symptoms with a normal liver scan. The goal is to improve early detection and monitoring of liver diseases that are often diagnosed too late for effective treatment. Participants will provide a breath sample after fasting for 6 hours during a one-hour appointment at an NHS hospital. They will also answer health questions and allow access to relevant medical records. The study includes groups of participants with liver cancer, benign liver disorders, and healthy controls with non-specific gastrointestinal symptoms but normal liver scans. There are no treatments or drugs involved as it is an observational study. During the visit, researchers will collect breath samples and health information to measure the diagnostic accuracy of the breath test for detecting liver cancer. The breath collection is non-invasive and safe. Participants will not receive direct health benefits from taking part, but the results may help develop an easier way to detect liver disease in the future. The study is led by Imperial College London and takes place in NHS hospitals across the UK.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female adults aged 18 years or older
  • Participants with histologically or radiologically confirmed hepatocellular carcinoma or cholangiocarcinoma
  • Participants with liver cirrhosis confirmed by imaging or biopsy
  • Participants with primary sclerosing cholangitis confirmed by MRCP/ERCP or biopsy
  • Participants with non-specific gastrointestinal symptoms but a normal liver scan
Not Eligible

You will not qualify if you...

  • Active infection or use of immunosuppressive medications within the past eight weeks
  • History of another cancer within the previous five years
  • Previous liver surgery
  • Prior chemotherapy, radiotherapy, or surgery for liver cancer
  • Medical conditions preventing breath sample collection
  • Pregnant women
  • Unable to provide informed written consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants provide breath samples to detect liver cancer and monitor liver conditions using volatile organic compound analysis.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Imperial College London

London, United Kingdom

Actively Recruiting

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Research Team

G

Georgios Karagiannidis, MBBS(Hon)

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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