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Recruiting NCT05971108

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

Trial Parameters

Condition Liver Cirrhosis
Sponsor Manchester University NHS Foundation Trust
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-08
Completion 2030-07-31
Interventions
Elecsys® GAAD

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.

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.

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