Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT04946773

Deep Liver Phenotyping and Immunology Study

Led by University of Oxford · Updated on 2022-04-06

100

Participants Needed

1

Research Sites

1024 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 successfully used in other studies. The investigators will compare samples from patients with cancer to those of patients with other diseases of the liver who are at risk of developing cancer in the future. The investigators aim to detect changes in the liver, blood, urine and/or bile of patients who have liver conditions that could tell us their risk of a future cancer. These changes could be in the types of white blood cells found within the liver, or, they may be in products secreted by liver cells. In the latter case the liver cells may release small pieces of their DNA that could be detected in the blood. When liver cells are dysfunctional, they may also change the types of metabolic products that they produce, and the investigators may be able to detect these changes in the urine or bile.

CONDITIONS

Official Title

Deep Liver Phenotyping and Immunology Study

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years to 75 years.
  • Diagnosed with a malignancy or clinical suspicion of malignancy affecting the liver or biliary tree (Malignancy Cohort).
  • Patients with confirmed chronic non-malignant hepatobiliary disease (Control Cohort).
  • Willing to undergo ultrasound guided liver fine needle aspiration (FNA) if applicable.
  • Underwent appropriate clinical imaging of the upper abdomen (US/CT/MRI) within the last 12 months.
  • Full blood count and coagulation profile checked within 30 days prior to FNA procedure (for those undergoing FNA).
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent.
  • Pregnancy.
  • Investigator concerns about the safety or appropriateness of study participation.
  • Significant comorbid medical conditions increasing risk of liver FNA.
  • Coagulopathy with INR >1.3, PT >16 seconds, or platelet count <100 x 10^3/L.
  • Known bleeding disorders such as haemophilia.
  • Current use of oral or injectable anticoagulant medication.
  • Current use of oral antiplatelet agents.
  • Presence of ascites.

AI-Screening

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Trial Site Locations

Total: 1 location

1

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

R

Rory J Peters

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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