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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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: vocal-study@imperial.ac.uk Phone: +44 (0)20 7594 3396

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
United Kingdom
Imperial College London
RECRUITING
London
Contact Information
Primary
Georgios Karagiannidis, MBBS(Hon)
vocal-study@imperial.ac.uk
+02075943396
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 750
Treatments
participants with liver cancer
Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma
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
healthy controls
Non-specific gastrointestinal symptoms, but a radiologically-normal liver
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov