The Detection of Small Early Liver Cancer With Natural History Follow up (SELINA)

September 5, 2022 updated by: University of Oxford
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Hepatology Clinical Trial Unit, John Radcliffe Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above

Description

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/exclusion criteria)
  4. Participants of the Pearl study
  5. Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
  6. 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).

Exclusion Criteria for Imaging Subgroup

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Small HCC with Cirrhosis
200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis
Other: Blood & 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
Small HCC without Cirrhosis
50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis
Other: Blood & 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
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
Other: Imaging
MRI & MRE Scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers associated with small HCC (Early detection [EDx] biomarkers)
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
Throughout study to completion; up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic ability of Early Detection (EDx) bio-markers
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.
Throughout study to completion; up to 5 years
Whether combinations of EDx tests improve the diagnostic and prognostic performance
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.
Throughout study to completion; up to 5 years
Proportion of patients with HCC events according to time since treatment with curative intent.
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..
Throughout study to completion; up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Nottingham
Cancer Research UK
Glasgow Caledonian University
Perspectum
Roche Diagnostic Ltd.
OncImmune Ltd

Investigators

  • Principal Investigator: Ellie Barnes, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Anticipated)

June 1, 2035

Study Completion (Anticipated)

June 1, 2035

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SELINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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