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Prospective Cohort for Early Detection of Liver Cancer

Sponsor: University of Oxford

NCT ID: NCT05541601

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Blood and Urine samples (other)
How long the study runs
Study runs about 185 months (dates as stated)
About the drug or intervention
Blood and Urine samples — other: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 100 Years
Who
All
Number of participants
3,000
Started
2022-02-23
Last checked
2022-09

Plain English Summary

What is this study?

  • • Testing a new treatment for cirrhosis
  • • Clinical study - 3,000 participants
  • • This study aims to recruit 3000 people with liver cirrhosis into a Prospective cohort for early detection of Liver cancer - the Pearl cohort

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with cirrhosis

Where?

  • • Oxford - Hepatology Clinical Trial Unit, John Radcliffe Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

CirrhosisHepatocellular Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 100 Years
  • Who can join: All genders

What the study is looking for

  • ✓Patients of all genders, age \>18 years
  • ✓Participant is willing and able to give agreement to take part for participation in the study.
  • ✓Cirrhosis Diagnosis Definition
  • ✓Histological assessment (Ishak stage 5 or 6) or
  • ✓At least one of the following:

Who cannot take part

  • ✗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
See the full 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

Where Is This Study? (1 UK site)

Hepatology Clinical Trial Unit, John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Eleanor Barnes, Profellie.barnes@ndm.ox.ac.uk

How to Get in Touch

Study Coordinator

Sponsor contact

CONTACT

deliver-pearl@ndm.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2022-09