Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC

Not Applicable

Recruiting

Brief Summary: Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death.

The goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis.

The main questions it aims to answer are:

* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC?

* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations?

* Does the new surveillance pathway improve adherence?

Researchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.

Recruitment & Eligibility

Inclusion Criteria

• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance

Exclusion Criteria

Pregnancy/breast-feeding.
Patients who do not have liver cirrhosis
Patients who already have hepatocellular carcinoma
Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.

Arm && Interventions

Group	Intervention	Description
Patients with liver cirrhosis eligible for HCC Surveillance	Elecsys® GAAD	Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests.

Primary Outcome Measures

Name	Time	Method
Incidence of hepatocellular carcinoma diagnosis	2 years	Incidence recorded as number of cases per study cohort
Stage of hepatocellular carcinoma at diagnosis	2 years	Barcelona Clinic Liver Cancer (BCLC) stage 0-D

Secondary Outcome Measures

Name	Time	Method
Rates of discontinuation	2 years	• Count (%) of surveillance discontinuation, defined as no visit \>12 months.
Rates of curative treatment	2 years	Rates of curative treatment being offered (%) will be recorded on an intention to treat (ITT) basis from Multi-Disciplinary Team (MDT) meeting outcomes.
Rates of adherence	2 years	• Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment.
Survival rates	7 years	Long-term follow up data will be collected to determine rates of survival following HCC diagnosis at 1-year, 3-years and 5-years.
Rates of false positives for each combination of diagnostic tests	2 years	Count (%) of True/False positives for each test (against magnetic resonance imaging (MRI) / computerised tomography (CT)) will be reported. Results from different tests (and their (meaningful) combination) will be tabulated against each other: * Alpha-fetoprotein (AFP) vs GAAD * Ultrasound scan (USS) vs GAAD * AFP+ USS vs GAAD * AFP+USS vs GAAD +USS * AFP/GAAD/USS/AFP+USS/GAAD+USS vs MRI/CT for those who proceed to confirmatory imaging.

Locations (1): Manchester University NHS Foundation Trust
🇬🇧
Manchester, Greater Manchester, United Kingdom

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