Prospective Cohort for Early Detection of Liver Cancer

Recruiting now

Conditions studied: Cirrhosis, Hepatocellular Carcinoma

In brief

This study aims to recruit 3000 people with liver cirrhosis into a Prospective cohort for early detection of Liver cancer - the Pearl cohort. The study team believe that using a combination of novel tests may improve the detection of early Hepatocellular Carcinoma (HCC).

Key facts

Study ID

NCT05541601

Run by

University of Oxford

People needed

3000

Starts

2022-02-23

Expected to finish

2037-07-01

Last updated by the study team

2022-09-15

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of all genders, age >18 years
• Participant is willing and able to give informed consent for participation in the study.
• Evidence of cirrhosis CP A or B (as defined below, cirrhosis ever diagnosed), with an underlying aetiology of at least one of the following: chronic Hepatitis B Virus (HBV) infection, chronic Hepatitis C Virus (HCV) infection, alcoholic liver disease, non-alcoholic fatty liver disease or haemochromatosis
• Cirrhosis Diagnosis Definition
• Histological assessment (Ishak stage 5 or 6) or
• At least one of the following:
• i. Validated non-invasive marker of fibrosis including fibroscan, AST to Platelet Ratio Index (APRI) score >2 or Enhanced Liver Fibrosis (ELF) score >10.48 or Fibrotest score >0.73. Fibroscan readings should be assessed by aetiology as below:
• HBV: >=10 kPa
• HCV: >=14.5 kPa
• Alcoholic Liver Disease (ALD): >=19.5 kPa
• Non-alcoholic fatty liver disease (NAFLD): >=15 kPa
• Haemochromatosis: >=12kPa ii. Evidence of varices at endoscopy or imaging in the context of a patent portal vein iii. Definitive radiological evidence of cirrhosis (i.e. nodularity of liver and splenomegaly on Ultrasound/CT)

You may not qualify if…

• Diagnosis of current OR historical hepatocellular carcinoma
• Liver transplant recipients or patients on active listing for liver transplantation
• Child-Pugh C cirrhosis
• In the view of the clinician, if the patient has a co-morbidity likely to lead to death within the following 12 months
• In the view of the clinician, if the patient was not thought to be suitable for HCC surveillance

Where it is running

• Hepatology Clinical Trial Unit, John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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