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

NHS Foundation Trust

Status: Enrolling

Conditions: Liver Cirrhosis; Hepatocellular Carcinoma

Treatments: Diagnostic Test: Elecsys® GAAD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05971108

B01938

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Patients with liver cirrhosis eligible for HCC Surveillance

Experimental group

Description:

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

Treatment:

Diagnostic Test: Elecsys® GAAD