Clinical trial · Observational
Prospective Cohort for Early Detection of Liver Cancer
NCT05541601CI-TRIAL-00060861PearlrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and Urine samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pearl Cohort
- description
- All 3000 patients recruited to the Pearl study
- interventionNames
- Other: Blood and Urine samples
Primary outcomes (3)
- 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
- description
- Diagnostic approaches to be tested will include: 1. detection of epigenetic (e.g. methylation profiling) and genetic mutations, and copy number variations in circulating tumour DNA; 2. multiparametric MRI liver imaging including MR biomarkers of inflammation, fibrosis, fat and iron content; 3. host genetic makeup (relevant variants identified through Genome Wide Association Studies); 4. detection of autoantibodies to tumour associated antigens; 5. epitope mapping of circulating antibody repertoire using random peptide libraries; 6. protein biomarkers including the L3 isoform of alphafetoprotein, and des-gammacarboxy- prothrombin; 7. proteomic and metabolomic profiling, including steroid metabolic signatures in urine.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKhanna K, Barnes E, Benselin J, Culver E, Irving W, Innes H, Pavlides M, Consortium D. Prospective cohort for early detection of liver cancer (Pearl): a study protocol. BMJ Open. 2024 Oct 1;14(10):e085541. doi: 10.1136/bmjopen-2024-085541. PMID 39353693