NCT05541601Recruiting
Prospective Cohort for Early Detection of Liver Cancer
Source: ClinicalTrials.gov · Last updated 15 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 1 Aug 2022
- Start date
- 23 Feb 2022
- Primary completion date
- Jul 2037
- Lead sponsor
- University of Oxford
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05541601
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 23 Feb 2022 to the primary completion date, Jul 2037
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Liver transplant recipients or patients on active listing for liver transplantation
Other
- Diagnosis of current OR historical hepatocellular carcinoma
- 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
Who the study is looking for
- 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:
- 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)
Age in the registry: 18 years to 100 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hepatology Clinical Trial Unit, John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.