Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
OTHERBlood & Urine Samples
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
OTHERImaging
MRI & MRE Scans
Sponsors
Cancer Research UK
Roche Diagnostic Ltd.
OncImmune Ltd
Perspectum
University of Nottingham
Glasgow Caledonian University
University of Oxford
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Participant is willing and able to give informed consent for participation in the study. 2. Male or Female aged 18 years or above. 3. Diagnosed with small HCC (Barcelona Clinic Liver Cancer Staging Criteria (BCLC) stage 0/A; 1-3 nodules \<3cm, preserved liver function, performance status 0) with liver cirrhosis from any aetiology 4. Diagnosed with small HCC (as above) and without cirrhosis 5. Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1 6. Patients with a diagnosis of HCC that was fully ablated or resected more than 6 months ago and now presenting with a new diagnosis of HCC in a different site in the liver may be included in the study 7. Histological confirmation is required to establish the diagnosis of HCC in patients without cirrhosis (imaging alone is not considered sufficient to establish the diagnosis of HCC).
Exclusion criteria
1. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to comply with the study procedures) 2. HCC with liver cirrhosis at BCLC stage B/C 3. Patients who have had a previous liver transplant (note, it is permitted to enrol patients on the liver transplant waiting list if they fulfil all inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers associated with small HCC (Early detection [EDx] biomarkers) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prognostic ability of Early Detection (EDx) bio-markers | 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. |
| Whether combinations of EDx tests improve the diagnostic and prognostic performance | 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. |
| Proportion of patients with HCC events according to time since treatment with curative intent. | 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.. |
Countries
United Kingdom
Contacts
Primary ContactClinical Study Coordinator
Outcome results
None listed