Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC

NCT ID: NCT05971108

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2030-07-31

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.

Conditions

Liver Cirrhosis; Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with liver cirrhosis eligible for HCC Surveillance

Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests.

Group Type: EXPERIMENTAL

Elecsys® GAAD

Intervention Type: 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. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly early stage (sensitivity 78.9%), with 91.4% specificity for both early and all stages, out-performing current standard of care (Chan et al. 2021). Elecsys® GAAD may be integrated into current surveillance practice to increase early-stage HCC detection rate, reduce unnecessary onward investigations and patient anxiety.

Interventions

Elecsys® GAAD

Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly early stage (sensitivity 78.9%), with 91.4% specificity for both early and all stages, out-performing current standard of care (Chan et al. 2021). Elecsys® GAAD may be integrated into current surveillance practice to increase early-stage HCC detection rate, reduce unnecessary onward investigations and patient anxiety.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Unity Insights

UNKNOWN

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Varinder Athwal, MRCP PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust

Locations

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Varinder Athwal, PhD

Role: CONTACT

varinder.athwal@mft.nhs.uk

0300 3309444

Christopher Mysko, MClinEd MRCP

Role: CONTACT

christopher.mysko@mft.nhs.uk

0300 3309444

Facility Contacts

Christopher Mysko, MClinEd MRCP

Role: primary

christopher.mysko@mft.nhs.uk

07848471145

Other Identifiers

B01938

Identifier Type: -

Identifier Source: org_study_id