About this trial
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
Qualifiers
None
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Elecsys® GAAD
Treatment groups
Sponsors and collaborators
Manchester University NHS Foundation Trust
Lead sponsor
University of Manchester
Collaborator
Roche Pharma AG
Collaborator
Unity Insights
Collaborator
Imperial College London
Collaborator