The Detection of Small Early Liver Cancer With Natural History Follow up
SELINA
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2022
CompletedFirst Submitted
Initial submission to the registry
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2035
September 10, 2022
September 1, 2022
13 years
August 1, 2022
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Prognostic ability of Early Detection (EDx) bio-markers
Throughout study to completion; up to 5 years
Whether combinations of EDx tests improve the diagnostic and prognostic performance
Throughout study to completion; up to 5 years
Proportion of patients with HCC events according to time since treatment with curative intent.
Throughout study to completion; up to 5 years
Study Arms (3)
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
Interventions
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
Eligibility Criteria
Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above
You may qualify if:
- 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).
You may not qualify if:
- HCC with liver cirrhosis at BCLC stage B/C
- 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).
- \. 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Cancer Research UKcollaborator
- Roche Diagnostic Ltd.collaborator
- OncImmune Ltdcollaborator
- Perspectumcollaborator
- University of Nottinghamcollaborator
- Glasgow Caledonian Universitycollaborator
Study Sites (1)
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellie Barnes
University of Oxford
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2022
First Posted
September 10, 2022
Study Start
May 23, 2022
Primary Completion (Estimated)
June 1, 2035
Study Completion (Estimated)
June 1, 2035
Last Updated
September 10, 2022
Record last verified: 2022-09