Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000292471
Ethics application status
Approved
Date submitted
14/02/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Elecsys® GAAD for Hepatocellular carcinoma (HCC) in a regional Australian setting
Scientific title
Feasibility of Elecsys® GAAD for Hepatocellular carcinoma (HCC) in a regional Australian setting
Secondary ID [1] 313973 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma (HCC) 336695 0
Condition category
Condition code
Cancer 333195 333195 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330560 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340756 0
Feasibility of the HCC surveillance pathway.
Timepoint [1] 340756 0
After patient's first surveillance visit post-recruitment.
Secondary outcome [1] 445001 0
Potential improvements to the pathway.
Timepoint [1] 445001 0
After patient's first surveillance visit post-recruitment.
Secondary outcome [2] 445000 0
Barriers to engagement with current HCC surveillance
Timepoint [2] 445000 0
After patient's first surveillance visit post-recruitment.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative analysis - Descriptive summary of demographics for those invited to and those agreed to be part of the study, number of tests (AFP, Elecsys ® GAAD, USS, CT and /or MRI), proportion of patients attending bi-annual appointment, number of HCC detected as per standard care, their stages and outcomes. All patients will continue in the surveillance programme, if agreeable, and long-term outcome data collected for up to 18 months after completion of study visits including blood results, MRI/CT scan results, treatment modalities received and survival rates.
Qualitative analysis - Data from the free text responses will undergo simple content or thematic analysis by the team of researchers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27649 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 43821 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 318469 0
Hospital
Name [1] 318469 0
Sunshine Coast Hospital and Health Service
Country [1] 318469 0
Australia
Funding source category [2] 318667 0
Other
Name [2] 318667 0
QIMR Berghofer Medical Research Institute
Country [2] 318667 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 320870 0
None
Name [1] 320870 0
Address [1] 320870 0
Country [1] 320870 0
Other collaborator category [1] 283444 0
Commercial sector/Industry
Name [1] 283444 0
Roche Diagnostics Pty Limited
Address [1] 283444 0
Country [1] 283444 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317085 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317085 0
Ethics committee country [1] 317085 0
Australia
Date submitted for ethics approval [1] 317085 0
25/11/2024
Approval date [1] 317085 0
24/01/2025
Ethics approval number [1] 317085 0
114429

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139950 0
Prof James O'Beirne
Address 139950 0
Sunshine Coast University Hospital, 6 Doherty St, Birtinya QLD 4575
Country 139950 0
Australia
Phone 139950 0
+61 752021046
Fax 139950 0
Email 139950 0
[email protected]
Contact person for public queries
Name 139951 0
James O'Beirne
Address 139951 0
Sunshine Coast University Hospital, 6 Doherty St, Birtinya QLD 4575
Country 139951 0
Australia
Phone 139951 0
+61 752021046
Fax 139951 0
Email 139951 0
[email protected]
Contact person for scientific queries
Name 139952 0
James O'Beirne
Address 139952 0
Sunshine Coast University Hospital, 6 Doherty St, Birtinya QLD 4575
Country 139952 0
Australia
Phone 139952 0
+61 752021046
Fax 139952 0
Email 139952 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24543Ethical approval    HREC_114429_approval.pdf
24544Informed consent form    GAAD_Participant information consent form, Version 1.1 - 14-01-2025 - final.pdf
24545Study protocol    GAAD_Research Protocol, Version 1.1 - 14-01-2025 - final.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.