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Trial Title:
Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC
NCT ID:
NCT05971108
Condition:
Liver Cirrhosis
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Fibrosis
Conditions: Keywords:
GAAD
hepatocellular carcinoma
cirrhosis
health inequalities
surveillance
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Elecsys® GAAD
Description:
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.
Arm group label:
Patients with liver cirrhosis eligible for HCC Surveillance
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.
Criteria for 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.
Gender:
All
Gender based:
Yes
Gender description:
Biological sex used in diagnostic algorithm
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Manchester University NHS Foundation Trust
Address:
City:
Manchester
Zip:
M13 9WL
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Christopher Mysko, MClinEd MRCP
Phone:
07848471145
Email:
christopher.mysko@mft.nhs.uk
Investigator:
Last name:
Varinder Athwal, MRCP PhD
Email:
Principal Investigator
Start date:
January 8, 2024
Completion date:
July 31, 2030
Lead sponsor:
Agency:
Manchester University NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Manchester
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Collaborator:
Agency:
Unity Insights
Agency class:
Other
Collaborator:
Agency:
Imperial College London
Agency class:
Other
Source:
Manchester University NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05971108
