RecruitingNCT05541601
Prospective Cohort for Early Detection of Liver Cancer
Sponsor
University of Oxford
Enrollment
3,000 participants
Start Date
Feb 23, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria12
- 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)
Exclusion Criteria5
- 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
Interventions
OTHERBlood and Urine samples
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05541601
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