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

NCT05971108 | Recruiting DMC

• 1 other identifier: B01938
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

GAAD; hepatocellular carcinoma; cirrhosis; health inequalities; surveillance

Outcome Measures

Primary Outcomes (2)

• Incidence of hepatocellular carcinoma diagnosis

  Incidence recorded as number of cases per study cohort

  2 years

• Stage of hepatocellular carcinoma at diagnosis

  Barcelona Clinic Liver Cancer (BCLC) stage 0-D

  2 years

Secondary Outcomes (5)

• Rates of false positives for each combination of diagnostic tests

  2 years

• Rates of curative treatment

  2 years

• Rates of adherence

  2 years

• Rates of discontinuation

  2 years

• Survival rates

  7 years

Study Arms (1)

Patients with liver cirrhosis eligible for HCC Surveillance

EXPERIMENTAL

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

Diagnostic Test: Elecsys® GAAD

Interventions

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. 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.

Patients with liver cirrhosis eligible for HCC Surveillance

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological sex used in diagnostic algorithm
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator
• Roche Pharma AG: collaborator
• Unity Insights: collaborator
• Imperial College London: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Varinder Athwal, MRCP PhD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Varinder Athwal, PhD

CONTACT

0300 3309444; varinder.athwal@mft.nhs.uk

Christopher Mysko, MClinEd MRCP

CONTACT

0300 3309444; christopher.mysko@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 2, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)