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

Sponsor: University of Oxford

NCT ID: NCT05534906

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Blood & Urine Samples (other), Imaging (other)
How long the study runs
Study runs about 157 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 100 Years
Who
All
Number of participants
250
Started
2022-05-23
Last checked
2022-09

Plain English Summary

What is this study?

  • • Testing a new treatment for hepatocellular carcinoma
  • • Clinical study - 250 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with hepatocellular carcinoma

Where?

  • • Oxford - Hepatology Clinical Trial Unit, John Radcliffe Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Hepatocellular Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 100 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participant is willing and able to give agreement to take part 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,...
  • ✓Diagnosed with small HCC (as above) and without cirrhosis
  • ✓Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1

Who cannot take part

  • ✗Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels...
  • ✗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...
  • ✗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...
See the full criteria
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).

Where Is This Study? (1 UK site)

Hepatology Clinical Trial Unit, John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Eleanor Barnes, Profellie.barnes@ndm.ox.ac.uk

How to Get in Touch

Clinical Study Coordinator

Sponsor contact

CONTACT

deliver-selina@ndm.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2022-09