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

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

Recruiting
18 years and older
All
Phase N/A

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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.

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.

Study details
    Liver Cirrhosis
    Hepatocellular Carcinoma

NCT05971108

Manchester University NHS Foundation Trust

14 February 2024

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