Early detection of liver cancer in patients with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: deliver-pearl@ndm.ox.ac.uk

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Abbreviated non-contrast MRI versus ultrasound for finding liver cancer in people with cirrhosis

  We will test whether shorter MRI scans without contrast find liver cancer more reliably than routine ultrasound in adults with cirrhosis or otherwise at high risk.

  Recruiting at 2 sites University of Oxford · Oxford, Oxon and 1 other locations · NCT06658782

• Using memantine to treat patients with cirrhosis and liver cancer

  This study is testing if memantine can help improve the health and quality of life for patients with liver cancer who can't have major treatments due to cirrhosis.

  Recruiting Phase 2/3 Inova Health Care Services · Fairfax, Virginia and 1 other locations · NCT06007846

• Treatment of advanced liver cancer with namodenoson in patients with severe cirrhosis

  This study is testing if a new drug called namodenoson can help people with advanced liver cancer and severe cirrhosis feel better and live longer compared to a placebo.

  Recruiting at 11 sites Phase 3 Can-Fite BioPharma · Dallas, Texas and 31 other locations · NCT05201404

• Fast-MRI to improve liver cancer surveillance in high-risk patients

  This trial will test whether adding a fast liver MRI to the routine six-month ultrasound finds early liver cancers sooner in adults with cirrhosis who have an annual HCC risk above 3%.

  Recruiting Assistance Publique - Hôpitaux de Paris · Bondy · NCT05095714

• Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis

  This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.

  Recruiting University Medical Center Ho Chi Minh City (UMC) · Ho Chi Minh City · NCT07918378

• EUS-guided coil and glue vs glue injection for bleeding gastric varices in cirrhosis

  This trial tests whether using endoscopic ultrasound to guide coils plus glue works better than glue alone for stopping bleeding from gastric varices in adults with cirrhosis.

  Recruiting Medanta, The Medicity, India · Orlando, Florida and 1 other locations · NCT07855913

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.