NCT05541601 Prospective Cohort for Early Detection of Liver Cancer
| NCT ID | NCT05541601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2037-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2022-02-23 with a primary completion date of 2037-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Study Coordinator
✉ deliver-pearl@ndm.ox.ac.ukEllie Barnes
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT05541601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05541601 currently recruiting?
Yes, NCT05541601 is actively recruiting participants. Contact the research team at deliver-pearl@ndm.ox.ac.uk for enrollment information.
Where is the NCT05541601 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT05541601 clinical trial?
NCT05541601 is sponsored by University of Oxford. The principal investigator is Ellie Barnes at University of Oxford. The trial plans to enroll 3,000 participants.