Prospective Cohort for Early Detection of Liver Cancer (Pearl)

University of Oxford

Status: Enrolling

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Other: Blood and Urine samples

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05541601

Pearl

Details and patient eligibility

About

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).

Full description

During a four-year follow-up period, around 100 Pearl patients are expected to be diagnosed with HCC. Blood, urine, clinical and imaging data will be collected over the follow up period. The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Pearl Cohort

Description:

All 3000 patients recruited to the Pearl study

Treatment:

Other: Blood and Urine samples