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

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Imaging; Other: Blood & Urine Samples

• Registration Number: NCT05534906
• Lead Sponsor: University of Oxford

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-23
• Study First Submitted: 2022-08-01
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Primary Completion: 2035-06
• Study Completion: 2035-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imaging Subgroup	Imaging	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
Small HCC with Cirrhosis	Blood & Urine Samples	200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis
Small HCC without Cirrhosis	Blood & Urine Samples	50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis

Primary Outcome Measures

Name	Time	Method
Biomarkers associated with small HCC (Early detection [EDx] biomarkers)	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 Outcome Measures

Name	Time	Method
Whether combinations of EDx tests improve the diagnostic and prognostic performance	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.
Prognostic ability of Early Detection (EDx) bio-markers	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.
Proportion of patients with HCC events according to time since treatment with curative intent.	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..

Trial Locations

Locations (1)

Hepatology Clinical Trial Unit, John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom