Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Incidence of hepatocellular carcinoma diagnosis
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Incidence of hepatocellular carcinoma diagnosis
Time Frame: 2 years
Incidence recorded as number of cases per study cohort
Stage of hepatocellular carcinoma at diagnosis
Time Frame: 2 years
Barcelona Clinic Liver Cancer (BCLC) stage 0-D
Secondary Outcomes
- Rates of discontinuation(2 years)
- Rates of curative treatment(2 years)
- Rates of adherence(2 years)
- Survival rates(7 years)
- Rates of false positives for each combination of diagnostic tests(2 years)