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

Hepatocellular Carcinoma Clinical Trial

— REVISE-HCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971108
• Other study ID #: B01938
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: July 31, 2030

Study information

• Verified date: February 2024
• Source: Manchester University NHS Foundation Trust
• Contact: Varinder Athwal, PhD
• Phone: 0300 3309444
• Email: varinder.athwal[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 31, 2030
• Est. primary completion date: July 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (5)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Imperial College London, Roche Pharma AG, Unity Insights, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hepatocellular carcinoma diagnosis	Incidence recorded as number of cases per study cohort	2 years
Primary	Stage of hepatocellular carcinoma at diagnosis	Barcelona Clinic Liver Cancer (BCLC) stage 0-D	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	Rates of adherence	• Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment.	2 years
Secondary	Rates of discontinuation	• Count (%) of surveillance discontinuation, defined as no visit >12 months.	2 years
Secondary	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.	7 years