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NCT05971108CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
657 (actual)
First submitted
24 May 2023
Start date
8 Jan 2024
Primary completion date
23 Sept 2026
Lead sponsor
Manchester University NHS Foundation Trust
NCT number
NCT05971108

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 657
  • From 8 Jan 2024 to the primary completion date, 23 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Manchester University NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.