Prospective Cohort for Early Detection of Liver Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
View:

⁃ 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)

Locations
Other Locations
United Kingdom
Hepatology Clinical Trial Unit, John Radcliffe Hospital
RECRUITING
Oxford
Contact Information
Primary
Study Coordinator
deliver-pearl@ndm.ox.ac.uk
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2037-07
Participants
Target number of participants: 3000
Treatments
Pearl Cohort
All 3000 patients recruited to the Pearl study
Related Therapeutic Areas
Sponsors
Collaborators: OncImmune Ltd, Cancer Research UK, University of Nottingham, Perspectum, Glasgow Caledonian University, Roche Diagnostic Ltd.
Leads: University of Oxford

This content was sourced from clinicaltrials.gov