Hepatocellular CarcinomaSELINANCT05534906
The Detection of Small Early Liver Cancer With Natural History Follow up
An observational study of Hepatocellular Carcinoma, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Blood & Urine Samples and Imaging
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2022to Jun 2035
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female aged 18 years or above.
- 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
- Diagnosed with small HCC (as above) and without cirrhosis
- Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1
- 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
- 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).
Who cannot join
- 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)
- HCC with liver cirrhosis at BCLC stage B/C
- 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/exclusion criteria)
- Participants of the Pearl study
- Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
- Patients who have received HCC specific therapy 3 months prior to study visit 1 (including resection, ablation [microwave/radiofrequency]), transarterial chemoembolization [TACE], select internal radiation therapy [SIRT] or stereotactic body radiation therapy [SBRT] 3, chemotherapy, immune modulators and other experimental therapies).
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Study Coordinator contact
United Kingdom1 site, 1 recruiting
- Recruiting
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Eleanor Barnes, Prof, ellie.barnes@ndm.ox.ac.uk
About this study
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Blood & Urine Samples, Imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood & Urine SamplesOther
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
ImagingOther
MRI \& MRE Scans
| Study group | Role | What they receive |
|---|---|---|
| Small HCC with Cirrhosis | 200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis Receives: Other: Blood & Urine Samples | |
| Small HCC without Cirrhosis | 50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis Receives: Other: Blood & Urine Samples | |
| 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 Receives: Other: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout study to completion; up to 5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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..
Measured: Throughout study to completion; up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start23 May 2022
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Roche Diagnostic Ltd., OncImmune Ltd, Perspectum, University of Nottingham, Glasgow Caledonian University
- Responsible party
- Sponsor
- Investigators
- Ellie Barnes, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534906
- Sponsor's protocol ID
- SELINA
- Acronym
- SELINA
- Status last verified
- Sep 2022
- First submitted
- 1 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No