The Detection of Small Early Liver Cancer With Natural History Follow up
NCT ID: NCT05534906
Last Updated: 2022-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2022-05-23
2035-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Small HCC with Cirrhosis
200 patients diagnosed with small HCC (as defined in Eligibility Criteria) and cirrhosis
Blood & Urine Samples
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
Small HCC without Cirrhosis
50 patients diagnosed with small HCC (as defined in Eligibility Criteria) but without cirrhosis
Blood & Urine Samples
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
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
Imaging
MRI \& MRE Scans
Interventions
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Blood & Urine Samples
Blood and urine samples will be collected to help identify biomarkers that can be used to detect liver cancer at the earliest possible time
Imaging
MRI \& MRE Scans
Eligibility Criteria
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Inclusion Criteria
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
2. HCC with liver cirrhosis at BCLC stage B/C
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).
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).
18 Years
100 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Roche Diagnostic Ltd.
INDUSTRY
OncImmune Ltd
UNKNOWN
Perspectum
INDUSTRY
University of Nottingham
OTHER
Glasgow Caledonian University
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Ellie Barnes
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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DeLIVER Project Website
Other Identifiers
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SELINA
Identifier Type: -
Identifier Source: org_study_id
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