Early detection of liver cancer in patients with cirrhosis

Prospective Cohort for Early Detection of Liver Cancer

This study is testing new ways to find liver cancer early in people with cirrhosis by looking at blood, urine, and other health information over four years.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Oxford (Academic / other)
• Locations: 1 site (Oxford, Oxfordshire)
• Trial ID: NCT05541601 on ClinicalTrials.gov

What this trial studies

This study recruits 3000 individuals with liver cirrhosis to form a prospective cohort aimed at the early detection of hepatocellular carcinoma (HCC). Over a four-year follow-up, the study will collect blood, urine, clinical, and imaging data to identify biomarkers that may indicate the risk of developing HCC. The goal is to improve early detection methods through a combination of novel tests and clinical data analysis. Approximately 100 participants are expected to be diagnosed with HCC during the study period.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with a confirmed diagnosis of cirrhosis and specific underlying conditions such as chronic hepatitis B or C, alcoholic liver disease, or non-alcoholic fatty liver disease.

Not a fit: Patients without cirrhosis or those with other liver conditions not specified in the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and improved outcomes for patients at risk of liver cancer.

How similar studies have performed: Other studies have shown promise in using biomarkers for early detection of liver cancer, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

1. Patients of all genders, age \>18 years
2. Participant is willing and able to give informed consent for participation in the study.
3. 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

1. Histological assessment (Ishak stage 5 or 6) or
2. 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)

Exclusion Criteria:

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

Where this trial is running

Oxford, Oxfordshire

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

Study contacts

• Principal investigator: Ellie Barnes — University of Oxford
• Study coordinator: Study Coordinator

Conditions Cirrhosis; Hepatocellular Carcinoma