Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
NCT Number: NCT05534906
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for Imaging Subgroup
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
Time frame: Throughout study to completion; up to 5 years
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
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
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
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..
Contact information is provided by the study sponsor or research team.
University of Oxford
Other
Acronym: SELINA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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