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NCT Number: NCT05971108

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location status: Recruiting

Location contact

Christopher Mysko, MClinEd MRCP

CONTACT

[email protected]

07848471145

Varinder Athwal, MRCP PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of hepatocellular carcinoma diagnosis

    Time frame: 2 years

    Incidence recorded as number of cases per study cohort

  2. Stage of hepatocellular carcinoma at diagnosis

    Time frame: 2 years

    Barcelona Clinic Liver Cancer (BCLC) stage 0-D

Secondary outcomes

  1. Rates of false positives for each combination of diagnostic tests

    Time frame: 2 years

    Count (%) of True/False positives for each test (against magnetic resonance imaging (MRI) / computerised tomography (CT)) will be reported.

    Results from different tests (and their (meaningful) combination) will be tabulated against each other:

    • Alpha-fetoprotein (AFP) vs GAAD
    • Ultrasound scan (USS) vs GAAD
    • AFP+ USS vs GAAD
    • AFP+USS vs GAAD +USS
    • AFP/GAAD/USS/AFP+USS/GAAD+USS vs MRI/CT for those who proceed to confirmatory imaging.

  2. Rates of curative treatment

    Time frame: 2 years

    Rates of curative treatment being offered (%) will be recorded on an intention to treat (ITT) basis from Multi-Disciplinary Team (MDT) meeting outcomes.

  3. Rates of adherence

    Time frame: 2 years

    • Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment.

  4. Rates of discontinuation

    Time frame: 2 years

    • Count (%) of surveillance discontinuation, defined as no visit >12 months.

  5. Survival rates

    Time frame: 7 years

    Long-term follow up data will be collected to determine rates of survival following HCC diagnosis at 1-year, 3-years and 5-years.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Mysko, MClinEd MRCP

CONTACT

[email protected]

0300 3309444

Varinder Athwal, PhD

CONTACT

[email protected]

0300 3309444

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Imperial College London
  • Roche Pharma AG
  • Unity Insights
  • University of Manchester

Registry information

Official study title

Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma

Acronym: REVISE-HCC

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Aug 2, 2023
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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