Liver CirrhosisPhase 4REVISE-HCCNCT05971108
Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
A Phase 4 study testing Elecsys® GAAD in people with Liver Cirrhosis and Hepatocellular Carcinoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatocellular Carcinoma
- What is being tested?
- Elecsys® GAAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2024to 23 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
About this study
Official title: Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
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.
Read more
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
- Being tested
- Elecsys® GAAD
- Keywords
- GAAD, hepatocellular carcinoma, cirrhosis, health inequalities, surveillance
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecsys® GAADDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Elecsys® GAAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatocellular carcinoma diagnosis
Incidence recorded as number of cases per study cohort
Measured: 2 years
Stage of hepatocellular carcinoma at diagnosis
Barcelona Clinic Liver Cancer (BCLC) stage 0-D
Measured: 2 years
Secondary outcomes (5)
Rates of false positives for each combination of diagnostic tests
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.
Measured: 2 years
Rates of curative treatment
Rates of curative treatment being offered (%) will be recorded on an intention to treat (ITT) basis from Multi-Disciplinary Team (MDT) meeting outcomes.
Measured: 2 years
Rates of adherence
- Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment.
Measured: 2 years
Rates of discontinuation
- Count (%) of surveillance discontinuation, defined as no visit >12 months.
Measured: 2 years
Survival rates
Long-term follow up data will be collected to determine rates of survival following HCC diagnosis at 1-year, 3-years and 5-years.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start8 Jan 2024
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 4 biomarker validation - prospective, real-world, within subjects comparison
- Masking
- None (open label)
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester, Unity Insights, Imperial College London, Roche Diagnostic Ltd.
- Responsible party
- Sponsor
- Investigators
- Varinder Athwal, MRCP PhD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971108
- Sponsor's protocol ID
- B01938
- Acronym
- REVISE-HCC
- Status last verified
- Oct 2026
- First submitted
- 24 May 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05971108
- Acronym / sponsor ID
- REVISE-HCC / B01938
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma
- Keywords
- GAAD, hepatocellular carcinoma, cirrhosis, health inequalities, surveillance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester, Unity Insights, Imperial College London, Roche Diagnostic Ltd.
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 4 biomarker validation - prospective, real-world, within subjects comparison
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis eligible for HCC Surveillance | Experimental | Diagnostic Test: Elecsys® GAADReal-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elecsys® GAADElecsys® 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. | Diagnostic test | Patients with liver cirrhosis eligible for HCC Surveillance |
Primary outcome
Incidence of hepatocellular carcinoma diagnosis
Time frame: 2 years
Incidence recorded as number of cases per study cohort
Stage of hepatocellular carcinoma at diagnosis
Time frame: 2 years
Barcelona Clinic Liver Cancer (BCLC) stage 0-D
5 secondary outcomes
Rates of false positives for each combination of diagnostic tests
Time frame: 2 years
Rates of curative treatment
Time frame: 2 years
Rates of adherence
Time frame: 2 years
Rates of discontinuation
Time frame: 2 years
Survival rates
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varinder Athwal, MRCP PhD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elecsys® GAAD in people with Liver Cirrhosis and Hepatocellular Carcinoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatocellular carcinoma diagnosis (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.