At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Elecsys® GAAD (diagnostic test)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- Elecsys® GAAD — diagnostic test: Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 657
- Started
- 2024-01-08
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for liver cirrhosis
- • Phase4 - 657 participants
- • Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with liver cirrhosis
Where?
- • Manchester - Manchester University NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
Who cannot take part
- ✗Pregnancy/breast-feeding.
- ✗Patients who do not have liver cirrhosis
- ✗Patients who already have hepatocellular carcinoma
See the full criteria
Where Is This Study? (1 UK site)
Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom