Clinical trial NCT05971108: Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
Official title: Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Hepatocellular Carcinoma
Keywords: GAAD
hepatocellular carcinoma
cirrhosis
health inequalities
surveillance
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
name: Roche Pharma AG
name: Unity Insights
name: Imperial College London
First posted: 2023-08-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hepatocellular carcinoma diagnosis
timeFrame: 2 years
measure: Stage of hepatocellular carcinoma at diagnosis
timeFrame: 2 years
Secondary outcomes:
measure: Rates of false positives for each combination of diagnostic tests
timeFrame: 2 years
measure: Rates of curative treatment
timeFrame: 2 years
measure: Rates of adherence
timeFrame: 2 years
measure: Rates of discontinuation
timeFrame: 2 years
measure: Survival rates
timeFrame: 7 years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Varinder Athwal, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References: