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Trial Title:
The Detection of Small Early Liver Cancer With Natural History Follow up
NCT ID:
NCT05534906
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Blood & Urine Samples
Description:
Blood and urine samples will be collected to help identify biomarkers that can be used to
detect liver cancer at the earliest possible time
Arm group label:
Small HCC with Cirrhosis
Arm group label:
Small HCC without Cirrhosis
Intervention type:
Other
Intervention name:
Imaging
Description:
MRI & MRE Scans
Arm group label:
Imaging Subgroup
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.
Criteria for eligibility:
Study pop:
Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without
cirrhosis (N=50) aged 18 years and above
Sampling method:
Probability Sample
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Address:
City:
Oxford
Zip:
OX3 9DU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Eleanor Barnes, Prof
Email:
ellie.barnes@ndm.ox.ac.uk
Start date:
May 23, 2022
Completion date:
June 2035
Lead sponsor:
Agency:
University of Oxford
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Collaborator:
Agency:
Roche Diagnostic Ltd.
Agency class:
Industry
Collaborator:
Agency:
OncImmune Ltd
Agency class:
Other
Collaborator:
Agency:
Perspectum
Agency class:
Industry
Collaborator:
Agency:
University of Nottingham
Agency class:
Other
Collaborator:
Agency:
Glasgow Caledonian University
Agency class:
Other
Source:
University of Oxford
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05534906
https://deliver.cancer.ox.ac.uk/
