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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.