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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| Roche Diagnostic Ltd. | INDUSTRY |
| OncImmune Ltd | UNKNOWN |
| Perspectum |
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The SELINA study will recruit 200 patients with cirrhosis and small HCC and 50 patients with HCC but without cirrhosis (most of whom are expected to have FLD). Blood, urine and liver tissue samples (where available) will be collected for laboratory analysis. In a subgroup of patients (N=80, around 64 patients with HCC with liver cirrhosis and around 16 patients with HCC without liver cirrhosis), additional magnetic resonance liver imaging will be performed. The findings of the SELINA study aim to identify biomarkers that can be used to detect liver cancer at the earliest possible time, something we expect will increase the survival rate of HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small HCC with Cirrhosis | 200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis |
| |
| Small HCC without Cirrhosis | 50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis |
| |
| Imaging Subgroup | In a subgroup of patients (N=80, around 64 patients with HCC with liver cirrhosis and around 16 patients with HCC without liver cirrhosis), additional magnetic resonance liver imaging & elastography will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood & Urine Samples | Other | Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers associated with small HCC (Early detection [EDx] biomarkers) | Classification performance metrics of EDx biomarkers, in cirrhosis patients with small HCC compared to non-HCC cirrhosis patients | Throughout study to completion; up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic ability of Early Detection (EDx) bio-markers | Ability of EDx biomarkers to discriminate between individuals who go onto develop adverse outcomes (e.g. HCC rapid tumour progression, liver decompensation, liver related mortality, liver transplantation) versus those who do not. Measured via Harrell's concordance index and Royston's D statistic. | Throughout study to completion; up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Imaging Subgroup
1. Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. claustrophobia, metal implants/fragments, implants, pregnancy, other conditions the scanner operator deems unsafe for MR scanning).
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Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Coordinator | Contact | deliver-selina@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 |
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| Label | URL |
|---|---|
| DeLIVER Project Website | View source |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| INDUSTRY |
| University of Nottingham | OTHER |
| Glasgow Caledonian University | OTHER |
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| Imaging | Other | MRI & MRE Scans |
|
| Whether combinations of EDx tests improve the diagnostic and prognostic performance | Model fit statistics comparing univariate and multivariate models, including Harrell's adequacy index. The change in model discrimination (e.g. Delta Concordance-index and Delta D-statistic) will also be considered. | Throughout study to completion; up to 5 years |
| Proportion of patients with HCC events according to time since treatment with curative intent. | To study the natural history of small HCC. Proportion of patients with HCC recurrence, all-cause mortality, liver mortality etc, according to time since treatment with curative intent.. | Throughout study to completion; up to 5 years |
| 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 |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |