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

RecruitingNA

Sponsor: Manchester University NHS Foundation Trust

Conditions: Liver Cirrhosis, Hepatocellular Carcinoma

Interventions: Elecsys® GAAD

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Manchester, Greater Manchester, United Kingdom