Actively Recruiting
Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
Led by Manchester University NHS Foundation Trust · Updated on 2025-09-24
600
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
Sponsors
M
Manchester University NHS Foundation Trust
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
You will not qualify if you...
- Pregnancy or breastfeeding
- Patients who do not have liver cirrhosis
- Patients who already have hepatocellular carcinoma
- Patients unable to understand, retain, and weigh information to make an informed decision
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
V
Varinder Athwal, PhD
CONTACT
C
Christopher Mysko, MClinEd MRCP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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