Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| Roche Diagnostic Ltd. | INDUSTRY |
| OncImmune Ltd | UNKNOWN |
| Perspectum |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pearl Cohort | All 3000 patients recruited to the Pearl study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. | Diagnostic approaches to be tested will include:
| When 50 cases of HCC have accumulated through to study completion; up to 5 years |
| Specificity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. | Diagnostic approaches to be tested will include:
| When 50 cases of HCC have accumulated through to study completion; up to 5 years |
| Positive/Negative predictive values of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. | Diagnostic approaches to be tested will include:
|
| Measure | Description | Time Frame |
|---|---|---|
| To develop models that can be used to "risk-stratify" cirrhosis patients according to their future risk of HCC | The Harrell's Concordance Index (C-index) will be calculated for each biomarker/model of interest. The minimum and maximum C-index scores are 0 and 1, respectively, where the higher the score the better the biomarker/model is at identifying HCC risk. C-index values indicate the degree to which individuals who develop HCC have a higher risk score than those who do not. C-index values will be adapted to incorporate non-HCC mortality as a competing risk. The C-index value will be used to identify the biomarkers/models with the best discriminative ability. |
Not provided
Inclusion Criteria:
Cirrhosis Diagnosis Definition
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | deliver-pearl@ndm.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ellie Barnes | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatology Clinical Trial Unit, John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39353693 | Derived | Khanna 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. |
| Label | URL |
|---|---|
| DeLIVER Project Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
| INDUSTRY |
| University of Nottingham | OTHER |
| Glasgow Caledonian University | OTHER |
Not provided
Not provided
Not provided
|
| When 50 cases of HCC have accumulated through to study completion; up to 5 years |
| Throughout study to completion; 5 years |
| To better understand the incidence of HCC in a UK population stratified by underlying cirrhosis aetiology | Cumulative incidence of HCC according to cirrhosis aetiology | At 1, 3 and 5 year post- baseline. |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |