Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT05534906

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

Led by University of Oxford · Updated on 2022-09-10

250

Participants Needed

1

Research Sites

679 weeks

Total Duration

On this page

Sponsors

U

University of Oxford

Lead Sponsor

C

Cancer Research UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (BCLC stage 0/A; 1-3 nodules <3cm, preserved liver function, performance status 0) with liver cirrhosis from any cause.
  • Diagnosed with small HCC as above without cirrhosis.
  • Diagnosis of small HCC confirmed within 3 months of study Visit 1.
  • Patients with fully ablated or resected HCC more than 6 months ago presenting with new HCC at a different liver site may be included.
  • Histological confirmation required for HCC diagnosis in patients without cirrhosis.
Not Eligible

You will not qualify if you...

  • Patients judged unsuitable by the investigator to comply with study procedures.
  • HCC with liver cirrhosis at BCLC stage B or C.
  • Patients who have had a previous liver transplant (except those on transplant waiting list meeting criteria).
  • Participants of the Pearl study.
  • Patients with recurrent HCC at the same liver site after prior therapy.
  • Patients who received HCC-specific therapy within 3 months before study Visit 1 (including resection, ablation, TACE, SIRT, SBRT, chemotherapy, immune modulators, or experimental therapies).
  • For imaging subgroup: Any contraindication to MRI (e.g., claustrophobia, metal implants, pregnancy, or other unsafe conditions).

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Trial Site Locations

Total: 1 location

1

Hepatology Clinical Trial Unit, John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

C

Clinical Study Coordinator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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