Clinical trial NCT05541601: Prospective Cohort for Early Detection of Liver Cancer
Official title: Prospective Cohort for Early Detection of Liver Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis
Hepatocellular Carcinoma
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: Roche Diagnostic Ltd.
name: OncImmune Ltd
name: Perspectum
name: University of Nottingham
name: Glasgow Caledonian University
First posted: 2022-09-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Child-Pugh (CP) A or B cirrhosis with no current or historical diagnosis of HCC. Diagnosis of cirrhosis can be based on, laboratory, imaging or histology criteria (e.g. the latter including Ishak stage \>=5). Participants can be recruited to other interventional studies for treatment of cirrhosis or prevention of HCC prior to or during participation in the Pearl study.

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches.
timeFrame: When 50 cases of HCC have accumulated through to study completion; up to 5 years
measure: Specificity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches.
timeFrame: When 50 cases of HCC have accumulated through to study completion; up to 5 years
measure: 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.
timeFrame: When 50 cases of HCC have accumulated through to study completion; up to 5 years
Secondary outcomes:
measure: To develop models that can be used to "risk-stratify" cirrhosis patients according to their future risk of HCC
timeFrame: Throughout study to completion; 5 years
measure: To better understand the incidence of HCC in a UK population stratified by underlying cirrhosis aetiology
timeFrame: At 1, 3 and 5 year post- baseline.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Hepatology Clinical Trial Unit, John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Ellie Barnes
role: PRINCIPAL_INVESTIGATOR
References: