Detecting small early liver cancer through patient follow-up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SELINA study aims to recruit 250 patients, including those with cirrhosis and small hepatocellular carcinoma (HCC), to collect blood, urine, and liver tissue samples for laboratory analysis. A subgroup of 80 patients will undergo additional magnetic resonance imaging of the liver. The goal is to identify biomarkers that can facilitate the early detection of liver cancer, potentially improving survival rates for patients with HCC. This observational study will follow the natural history of the disease to gather critical data.

Why it matters

Who can join: the full rules

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 it's running

• Hepatology Clinical Trial Unit, John Radcliffe Hospital
  Oxford, Oxfordshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Ellie Barnes — University of Oxford
• Study coordinator: Clinical Study Coordinator
• Email: deliver-selina@ndm.ox.ac.uk

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.