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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
600
Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly early stage (sensitivity 78.9%), with 91.4% specificity for both early and all stages, out-performing current standard of care (Chan et al. 2021). Elecsys® GAAD may be integrated into current surveillance practice to increase early-stage HCC detection rate, reduce unnecessary onward investigations and patient anxiety.
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
RECRUITINGIncidence of hepatocellular carcinoma diagnosis
Incidence recorded as number of cases per study cohort
Time frame: 2 years
Stage of hepatocellular carcinoma at diagnosis
Barcelona Clinic Liver Cancer (BCLC) stage 0-D
Time frame: 2 years
Rates of false positives for each combination of diagnostic tests
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.
Time frame: 2 years
Rates of curative treatment
Rates of curative treatment being offered (%) will be recorded on an intention to treat (ITT) basis from Multi-Disciplinary Team (MDT) meeting outcomes.
Time frame: 2 years
Rates of adherence
• Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment.
Time frame: 2 years
Rates of discontinuation
• Count (%) of surveillance discontinuation, defined as no visit \>12 months.
Time frame: 2 years
Survival rates
Long-term follow up data will be collected to determine rates of survival following HCC diagnosis at 1-year, 3-years and 5-years.
Time frame: 7 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.