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

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.

NCT Number	NCT05971108
Lead Sponsor	Manchester University NHS Foundation Trust Collaborators: University of Manchester, Roche Pharma AG, Unity Insights, Imperial College London
Conditions	Liver Cirrhosis, Hepatocellular Carcinoma
Enrollment	600 participants
Start Date	2024-01-08
Primary Completion	2030-07-31 (estimated)
Study Completion	2030-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-24