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

University of Oxford

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Other: Imaging; Other: Blood & Urine Samples

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05534906

SELINA

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

250 participants in 3 patient groups

Small HCC with Cirrhosis

Description:

200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis

Treatment:

Other: Blood & Urine Samples

Small HCC without Cirrhosis

Description:

50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis

Treatment:

Other: Blood & Urine Samples

Imaging Subgroup

Description:

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

Treatment:

Other: Imaging