Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elecsys® GAAD.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
Overview
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.
Interventions
- Diagnostic test Elecsys® GAAD
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
Primary outcome measures
- Incidence of hepatocellular carcinoma diagnosis [Time frame: 2 years]
- Stage of hepatocellular carcinoma at diagnosis [Time frame: 2 years]
Secondary outcome measures (5)
- Rates of false positives for each combination of diagnostic tests [Time frame: 2 years]
- Rates of curative treatment [Time frame: 2 years]
- Rates of adherence [Time frame: 2 years]
- Rates of discontinuation [Time frame: 2 years]
- Survival rates [Time frame: 7 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 1 center
- Manchester University NHS Foundation Trust — Manchester
Identifiers
NCT: NCT05971108 · B01938