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RECRUITING
NCT05971108
NA

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

Sponsor: Manchester University NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-01-08

Completion Date

2030-07-31

Last Updated

2025-09-24

Healthy Volunteers

No

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 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.

Locations (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom