Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05534906

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatology Clinical Trial Unit, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Eleanor Barnes, Prof

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Exclusion criteria

for Imaging Subgroup

  • 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).

Treatment and study plan

Blood & Urine Samples

Other

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

Other

MRI & MRE Scans

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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..

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Study Coordinator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Acronym: SELINA

Important dates

Study start
2022
Primary completion
2035
Study completion
2035
First posted
Sep 10, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.