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Trial Title:
Prospective Cohort for Early Detection of Liver Cancer
NCT ID:
NCT05541601
Condition:
Cirrhosis
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood and Urine samples
Description:
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.
Arm group label:
Pearl Cohort
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Locations:
Facility:
Name:
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Address:
City:
Oxford
Zip:
OX3 9DU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Eleanor Barnes, Prof
Email:
ellie.barnes@ndm.ox.ac.uk
Start date:
February 23, 2022
Completion date:
July 2037
Lead sponsor:
Agency:
University of Oxford
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Collaborator:
Agency:
Roche Diagnostic Ltd.
Agency class:
Industry
Collaborator:
Agency:
OncImmune Ltd
Agency class:
Other
Collaborator:
Agency:
Perspectum
Agency class:
Industry
Collaborator:
Agency:
University of Nottingham
Agency class:
Other
Collaborator:
Agency:
Glasgow Caledonian University
Agency class:
Other
Source:
University of Oxford
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541601
https://deliver.cancer.ox.ac.uk/
