Clinical trial NCT05534906: The Detection of Small Early Liver Cancer With Natural History Follow up
Official title: The Detection of Small Early Liver Cancer With Natural History Follow up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: Roche Diagnostic Ltd.
name: OncImmune Ltd
name: Perspectum
name: University of Nottingham
name: Glasgow Caledonian University
First posted: 2022-09-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above

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.


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).

Primary outcomes:
measure: Biomarkers associated with small HCC (Early detection [EDx] biomarkers)
timeFrame: Throughout study to completion; up to 5 years
Secondary outcomes:
measure: Prognostic ability of Early Detection (EDx) bio-markers
timeFrame: Throughout study to completion; up to 5 years
measure: Whether combinations of EDx tests improve the diagnostic and prognostic performance
timeFrame: Throughout study to completion; up to 5 years
measure: Proportion of patients with HCC events according to time since treatment with curative intent.
timeFrame: Throughout study to completion; up to 5 years
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Hepatology Clinical Trial Unit, John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Ellie Barnes
role: PRINCIPAL_INVESTIGATOR
References: