Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05971108

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
Not Eligible

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

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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

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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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