None listed
Conditions
Brief summary
This research project aims to determine the feasibility of the Elecsys® GAAD blood test for hepatocellular carcinoma (HCC) surveillance in a regional Australian setting. Who is it for? You may be eligible for this study if you are an adult already undergoing HCC surveillance within the Sunshine Coast Hospital and Health Service. Study details Participants will undergo a single blood test, with the collected blood analysed using the Elecsys® GAAD assay. Findings will be reported to their treating gastroenterologist and participants will be followed up as required. Participants will be asked to complete online surveys regarding the feasibility of this HCC surveillance pathway. It is hoped that findings from this study may help design HCC surveillance systems that reduce the burden on the health care system and patients with liver disease, and lead to improved adherence, especially in regional settings.
Interventions
The Elecsys ® GAAD is a CE-marked in vitro diagnostic (IVD) multivariate index assay designed to assist in diagnosing early-stage HCC manufactured by Roche Diagnostics. This assay generates a semi-quantitative result by using an algorithm that combines measurements of Elecsys ® AFP and Elecsys ® PIVKA-II levels in serum and plasma, along with patient gender and age.
Participants will have a single venesection done as per standard care, with no additional blood required. This will be performed by
The Elecsys ® GAAD is a CE-marked in vitro diagnostic (IVD) multivariate index assay designed to assist in diagnosing early-stage HCC manufactured by Roche Diagnostics. This assay generates a semi-quantitative result by using an algorithm that combines measurements of Elecsys ® AFP and Elecsys ® PIVKA-II levels in serum and plasma, along with patient gender and age. Participants will have a single venesection done as per standard care, with no additional blood required. This will be performed by QML, the phlebotomy service across the Sunshine Coast. Patients will be recruited from a pre-existing HCC surveillance program. Blood samples will be sent to QML labs for analysis. Results of the assay will be provided to the treating clinician for interpretation prior to the patients subsequent HCC surveillance appointment. Positive results will be referred for further testing (e.g., CT/MRI) and consultation with the hepatology team to discuss the results. Non-detection will result in the patient continuing on normal 6-monthly HCC surveillance pathway. Surveillance adherence rates will be monitored via audit of clinical notes.
Sponsors
Sunshine Coast Hospital and Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients under the Sunshine Coast Hospital and Health Service catchment area for Hepatology currently under HCC surveillance will be eligible including; o 18 years of age and older o Have access to email for digital consent purposes o People with cirrhosis (any aetiology) o Compensated cirrhosis o Enrolled in HCC surveillance including Hepatitis B patients
Exclusion criteria
Patients not suitable include: o <18 years of age o Unable to give informed consent o Recurrent HCC, or previous or current treatment for HCC o Decompensated cirrhosis
Outcome results
None listed