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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: vocal-study@imperial.ac.uk Phone: +44 (0)20 7594 3396
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants with liver cancer | Histologically or radiologically-confirmed hepatocellular carcinoma or cholangiocarcinoma | ||
| participants with benign liver disorders |
| ||
| healthy controls | Non-specific gastrointestinal symptoms, but a radiologically-normal liver |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of VOC Analysis for Liver Cancer Detection | This outcome measures the ability of volatile organic compound (VOC) analysis in exhaled breath to accurately detect liver cancer. Breath samples will be analysed using thermal desorption gas chromatography-mass spectrometry (TD-GC-MS). The diagnostic accuracy will be determined by comparing VOC profiles with histological confirmation or radiological imaging as the reference standard. Sensitivity, specificity, and area under the receiver operating characteristic curve (AU-ROC) will be reported. | Day 1 |
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Inclusion Criteria:
Males and females
Adult participants ≥ 18 years old
Participants with either:
Exclusion Criteria:
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People from secondary or tertiary centers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Karagiannidis, MBBS(Hon) | Contact | +02075943396 | vocal-study@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| George Hanna | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | Recruiting | London | United Kingdom |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| D015209 | Cholangitis, Sclerosing |
| D008113 | Liver Neoplasms |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |