Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elecsys® GAAD | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with liver cirrhosis eligible for HCC Surveillance
- description
- Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests.
- interventionNames
- Diagnostic Test: Elecsys® GAAD
Primary outcomes (2)
- measure
- Incidence of hepatocellular carcinoma diagnosis
- timeFrame
- 2 years
- description
- Incidence recorded as number of cases per study cohort
- measure
- Stage of hepatocellular carcinoma at diagnosis
- timeFrame
- 2 years
- description
- Barcelona Clinic Liver Cancer (BCLC) stage 0-D
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available