Hepatocellular CarcinomaSELINANCT05534906
The Detection of Small Early Liver Cancer With Natural History Follow up
An observational study of Hepatocellular Carcinoma, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Blood & Urine Samples and Imaging
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2022to Jun 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female aged 18 years or above.
- 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
- Diagnosed with small HCC (as above) and without cirrhosis
- Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1
- 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
- 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).
Who cannot join
- 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)
- HCC with liver cirrhosis at BCLC stage B/C
- 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)
- Participants of the Pearl study
- Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
- 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).
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Study Coordinator contact
United Kingdom1 site, 1 recruiting
- Recruiting
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Eleanor Barnes, Prof, ellie.barnes@ndm.ox.ac.uk
About this study
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Blood & Urine Samples, Imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood & Urine SamplesOther
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
ImagingOther
MRI \& MRE Scans
| Study group | Role | What they receive |
|---|---|---|
| Small HCC with Cirrhosis | 200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis Receives: Other: Blood & Urine Samples | |
| Small HCC without Cirrhosis | 50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis Receives: Other: Blood & Urine Samples | |
| Imaging Subgroup | 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 Receives: Other: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with small HCC (Early detection [EDx] biomarkers)
Classification performance metrics of EDx biomarkers, in cirrhosis patients with small HCC compared to non-HCC cirrhosis patients
Measured: Throughout study to completion; up to 5 years
Secondary outcomes (3)
Prognostic ability of Early Detection (EDx) bio-markers
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.
Measured: Throughout study to completion; up to 5 years
Whether combinations of EDx tests improve the diagnostic and prognostic performance
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.
Measured: Throughout study to completion; up to 5 years
Proportion of patients with HCC events according to time since treatment with curative intent.
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..
Measured: Throughout study to completion; up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start23 May 2022
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Roche Diagnostic Ltd., OncImmune Ltd, Perspectum, University of Nottingham, Glasgow Caledonian University
- Responsible party
- Sponsor
- Investigators
- Ellie Barnes, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534906
- Sponsor's protocol ID
- SELINA
- Acronym
- SELINA
- Status last verified
- Sep 2022
- First submitted
- 1 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Detection of Small Early Liver Cancer With Natural History Follow up
- ClinicalTrials.gov ID
- NCT05534906
- Acronym / sponsor ID
- SELINA / SELINA
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Cancer Research UK, Roche Diagnostic Ltd., OncImmune Ltd, Perspectum, University of Nottingham, Glasgow Caledonian University
- Study start
- 23 May 2022 (actual)
- Primary completion
- Jun 2035 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Small HCC with Cirrhosis | – | Other: Blood & Urine Samples200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis |
| Small HCC without Cirrhosis | – | Other: Blood & Urine Samples50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis |
| Imaging Subgroup | – | Other: ImagingIn 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with small HCC with cirrhosis (N=200) or with HCC but without cirrhosis (N=50) aged 18 years and above
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female aged 18 years or above.
- 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
- Diagnosed with small HCC (as above) and without cirrhosis
- Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1
Key exclusion criteria (7 listed)
- 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)
- HCC with liver cirrhosis at BCLC stage B/C
- 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)
- Participants of the Pearl study
- Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood & Urine SamplesBlood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time | Other | Small HCC with Cirrhosis, Small HCC without Cirrhosis |
| ImagingMRI \& MRE Scans | Other | Imaging Subgroup |
Primary outcome
Biomarkers associated with small HCC (Early detection [EDx] biomarkers)
Time frame: 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
3 secondary outcomes
Prognostic ability of Early Detection (EDx) bio-markers
Time frame: Throughout study to completion; up to 5 years
Whether combinations of EDx tests improve the diagnostic and prognostic performance
Time frame: Throughout study to completion; up to 5 years
Proportion of patients with HCC events according to time since treatment with curative intent.
Time frame: Throughout study to completion; up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- DeLIVER Project WebsiteLink provided by the sponsor.
Related trials for Hepatocellular Carcinoma
Not yet recruitingPhase 3
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
RecruitingPhase 2
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma, HCC
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Study Coordinator contact
Ellie Barnes principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Coordinator (deliver-selina@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers associated with small HCC (Early detection [EDx] biomarkers) (time frame: Throughout study to completion; up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.