VOCAL2 Clinical Trial
Recruiting now
What is VOCAL2?
Early diagnosis of liver cancer is challenging because symptoms may not be noticeable at first. People with liver cirrhosis and primary sclerosing cholangitis (PSC) already undergo monitoring due to their higher risk of liver cancer. However, many people are unaware they have the conditions like PSC and so miss this opportunity.
To improve earlier liver cancer detection, Dr Karagiannidis is developing a simple breath test to help GPs decide who to refer for specialised tests. Dr Karagiannidis and his team have developed similar breath tests to detect oesophagus, bowel and pancreas cancers and now aims to create a single breath test for early detection of multiple digestive cancers.
| Trial Name | Development of a Breath Test Using Volatile Organic Markers for Monitoring Cirrhosis and Detecting Primary Liver Tumours (VOCAL2) |
| ClinicalTrials.gov Identifier/ UK/EU Register identifier | NCT06864195 |
| Phase | N/A |
| Intervention | N/A |
| Recruiting now? | Yes |
| Participating Centres |
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| Liver disease diagnosis | Primary sclerosing cholangitis (PSC) (The team is also looking for volunteers with other conditions) |
| Age | 18 to 90 years |
| Females: can I be pregnant? | No |
| Is IBD (inflammatory bowel disease) allowed? | Yes |
| Is there an ALP (alkaline phosphatase) requirement? | No |
| Can I take UDCA (Urso)? | Yes |
| Can I take biologics? | No |
| Can I take steroids? | No |
| Can I take immunosuppressive medications? | No |
| Can I take part if I have a stent? | Yes |
| Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed? | Yes (only if the infection was over 6 weeks ago) |
| Can I take part if I have had a liver transplant? | Unfortunately not, as transplant patients are on immunosuppressive medications. |
| Is cirrhosis allowed? | Yes |
| Previous studies and information | Information on previous studies |
| Are travel expenses covered? | No |
| Procedures and tests include: | On the day, the researcher will ask you to rinse your mouth with water and then provide breath samples by blowing into single-use breath collection bags via a mouthpiece. |
| How many study visits will there be? How long will each study visit be? | One visit, scheduled at a time when you are already visiting the hospital e.g. for a routine appointment or procedure.
You will be asked not to eat or drink for 6 hours beforehand (but water is allowed). |
| Duration of study (treatment duration/follow-up) | A single study visit at one time point. No need for follow-up. |
| Basic design of study | The researchers will compare breath samples collected from people with different conditions (including cancers) to look for ‘markers’ for liver cancer. These results will be used to further develop a breath test for GPs to use to help pick up cancers early. |
| Study website | VOCAL2 study website |
| Link to sponsor | The VOCAL2 study is being organised by the Department of Surgery and Cancer at Imperial College London and funded by Rosetrees and Stoneygate Trust. |
If you're interested in taking part, please email vocal-study@imperial.ac.uk