Detecting small early liver cancer through patient follow-up

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

This study is testing if collecting blood, urine, and liver samples from patients with cirrhosis and small liver cancer can help find early signs of liver cancer to improve survival rates.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Oxford (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Oxford, Oxfordshire)
• Trial ID: NCT05534906 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with small HCC, either with or without cirrhosis.

Not a fit: Patients who do not have a diagnosis of small HCC or those with advanced liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of liver cancer, significantly improving patient survival rates.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for liver cancer detection, suggesting that this approach may be effective.

Eligibility 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 this trial is running

Oxford, Oxfordshire

• 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

Conditions Hepatocellular Carcinoma