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Deep Liver Phenotyping and Immunology Study

Recruitingn/aAges 18 Years - 75 YearsAllUniversity of Oxford
NCT04946773 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Hepatocellular carcinoma (HCC) and cholangiocarcinoma are the two most common causes of primary liver cancer and HCC is the second highest cause of cancer death worldwide. It is known that most of these cancers occur in patients who already have a liver condition. Despite close monitoring of many patients who have liver disease with regular ultrasound scans, HCC and cholangiocarcinoma are often discovered at a late stage. This is because they rarely cause symptoms until they have reached an advanced stage. Early identification of these cancers would enable more patients to have curative treatments such as surgery or liver transplantation. The investigators want to collect blood and urine samples as well as small samples of cells directly from the liver. In some cases this will be done using a technique called liver fine needle aspiration. This technique is low risk and has been successf

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years to 75 years. Malignancy Cohort: extra inclusion criteria - Diagnosed with a malignancy or with clinical suspicion of a malignancy affecting the Liver or Biliary Tree. Control cohort: extra inclusion criteria \- Patients with confirmed chronic non-malignant hepatobiliary disease. Additional Inclusion Criteria for Patients Undergoing optional Liver FNA * Willing to undergo ultrasound guided liver FNA (unless specific contra-indications to the procedure apply). * Has undergone appropriate clinical imaging of the upper abdomen (US/CT/MRI) within the last 12 months. * Full blood count (FBC) and coagulation profile (Coag) checked within 30 days prior to FNA procedure (Baseline Visit). Exclusion Criteria: * Unable to consent. * Pregnancy. * Any concern by the investigator regarding the safe participation of the patient in the study; or investigator's consideration, for any other reason, that a patient is inappropriate for participation in the study. Additional Exclusion Criteria for Patients Undergoing optional Liver FNA (These criteria will exclude a patient from having FNA as part of the study) * Significant comorbid medical condition(s) which may in the opinion of the investigator increase the risk of an FNA Liver. * Coagulopathy - International Normalized Ratio (INR) \>1.3, Prothrombin Time (PT) \>16 seconds, Platelet count \<100 x 10\^3/L. * Known bleeding disorder (e.g. Haemophilia). * Current use of an oral/injectable anticoagulant medication. * Current use of an oral antiplatelet agent. * The presence of ascites.
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What it tests

  • Not listed
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Where

1 site
John Radcliffe Hospital
Oxford, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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