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.
Study Type
OBSERVATIONAL
Enrollment
250
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
MRI \& MRE Scans
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
RECRUITINGBiomarkers 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
Time frame: Throughout study to completion; up to 5 years
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.
Time frame: Throughout study to completion; up to 5 years
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.
Time frame: 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..
Time frame: Throughout study to completion; up to 5 years
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