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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorManchester University NHS Foundation Trust

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

600 Participants
are divided into 1 treatment group

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