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Recruiting NCT05541601

Prospective Cohort for Early Detection of Liver Cancer

— Observational Cirrhosis Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood and Urine samples.
Who it may be relevant to
Registry conditions: Cirrhosis, Hepatocellular Carcinoma. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed 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.

Interventions

  • Other Blood 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.

Primary outcome measures

  • Sensitivity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. [Time frame: When 50 cases of HCC have accumulated through to study completion; up to 5 years]
  • Specificity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. [Time frame: When 50 cases of HCC have accumulated through to study completion; up to 5 years]
  • Positive/Negative predictive values of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. [Time frame: When 50 cases of HCC have accumulated through to study completion; up to 5 years]
Secondary outcome measures (2)
  • To develop models that can be used to "risk-stratify" cirrhosis patients according to their future risk of HCC [Time frame: Throughout study to completion; 5 years]
  • To better understand the incidence of HCC in a UK population stratified by underlying cirrhosis aetiology [Time frame: At 1, 3 and 5 year post- baseline.]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Hepatology Clinical Trial Unit, John Radcliffe Hospital — Oxford

Publications

  • Khanna K, Barnes E, Benselin J, Culver E, Irving W, Innes H, Pavlides M, Consortium D. Prospective cohort for early detection of liver cancer (Pearl): a study protocol. BMJ Open. 2024 Oct 1;14(10):e085541. doi: 10.1136/bmjopen-2024-085541. PMID 39353693

Identifiers

NCT: NCT05541601 · Pearl

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗