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Trial registered on ANZCTR
Registration number
ACTRN12623000295640
Ethics application status
Approved
Date submitted
8/03/2023
Date registered
17/03/2023
Date last updated
30/05/2024
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of using automated APRI calculation in pathology on diagnosis of liver cirrhosis and linkage to care: The Cirrhosis Automated APRI Screening Evaluation (CAPRISE) Study
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Scientific title
The effect of using automated APRI calculation in pathology on diagnosis of liver cirrhosis and linkage to care: The Cirrhosis Automated APRI Screening Evaluation (CAPRISE) Study
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Secondary ID [1]
309148
0
None
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Universal Trial Number (UTN)
U1111-1289-4679
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Trial acronym
CAPRISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
liver cirrhosis
329255
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Condition category
Condition code
Oral and Gastrointestinal
326208
326208
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Public Health
326285
326285
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0
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Epidemiology
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Public Health
326286
326286
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will involve the automated calculation of:
1) Aspartate aminotransferase (AST) to platelet ratio index (APRI) = (AST level/ AST upper limit of normal)/platelet count)*100, where the AST upper limit of normal is lab and sex based, and
2) Fibrosis-4 (FIB-4) score calculation and reporting = (age*AST)/(platelet count*sqrt(ALT)
Reporting of these values will be in a separate report of 'Fibrosis scores' that will be available if a Full Blood Count (FBC) and Liver tests (LFTs) have been performed. Recommendations based on repeated, elevated values will also be included on the report with APRI >1.0 and FIB-4>2.67 for consideration of referral for further investigation of chronic liver disease risk and specialist referral if age appropriate and not already known to the service provider. Primary care physicians utilising the recommendations will have the opportunity to discuss these results with individuals prior to referral and counselling about risk of liver disease that requires further work up prior to diagnosis.
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Intervention code [1]
325596
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Early detection / Screening
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Comparator / control treatment
The comparator/baseline group with which the intervention will be compared to, is six months of historical laboratory data (from the same collection service of St Vincent's pathology) collected from August 2022-January 2023 prior to the intervention taking place.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Number (proportion) of APRI scores calculated of all blood test events reported by St Vincent's pathology in Melbourne conducted during the study period. Data will be extracted from the central laboratory's reporting system.
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Assessment method [1]
334089
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Timepoint [1]
334089
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At the conclusion of the study
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Primary outcome [2]
334090
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Number (proportion) of APRI scores greater than 1.0 reported by St Vincent's pathology in Melbourne conducted during the study period. Data will be extracted from the central laboratory's reporting system.
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Assessment method [2]
334090
0
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Timepoint [2]
334090
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At the conclusion of the study
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Primary outcome [3]
334091
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Number of Fibroscan referrals made in response to APRI score result > 1.0, operationalised as number of completed Fibroscan referrals generated online using a) the recommended St Vincent’s pathology Fibroscan referral link on the results blood slip, or St Vincent’s Pathology APRI calculation web page referral form link, per month
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Assessment method [3]
334091
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Timepoint [3]
334091
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At the conclusion of study
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Secondary outcome [1]
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Number (proportion) of individuals with an APRI > 1.0 who are referred for Fibroscan who are referred for Fibroscan appointment at St Vincent’s Hospital Melbourne within the study period, as identified by the online referral system/website that will be put in place (so that referrals from other sources can be distinguished apart)
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Assessment method [1]
419313
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Timepoint [1]
419313
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At the conclusion of study
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Secondary outcome [2]
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Number (proportion) of individuals with an APRI > 1.0 who undergo Fibroscan at St Vincent’s Hospital Melbourne who have cirrhosis confirmed on Fibroscan (liver stiffness measurement > 12.5kPa) as identified as identified following reporting of Fibroscan data on study database.
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Assessment method [2]
419314
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Timepoint [2]
419314
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At the conclusion of study
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Eligibility
Key inclusion criteria
All individuals aged 18 years and over who have liver function tests and full blood count performed at St Vincent’s Pathology between 9 August, 2022-December 31, 2023
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Blood tests performed during a hospital inpatient stay, defined by St Vincent’s Pathology records (blood collection site).
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100000
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Accrual to date
78947
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
313350
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Other
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Name [1]
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Gilead Sciences (Gilead Fellowship Research Grant)
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Address [1]
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Gilead Grants
Gilead Sciences
333 Lakeside Drive
Foster City, CA 94404
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Country [1]
313350
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United States of America
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Melbourne
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Address
41 Victoria Pde
Fitzroy VIC 3065
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Country
Australia
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Secondary sponsor category [1]
315097
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None
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Name [1]
315097
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Address [1]
315097
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Country [1]
315097
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312571
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
312571
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41 Victoria Pde, Fitzroy VIC 3065
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Ethics committee country [1]
312571
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Australia
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Date submitted for ethics approval [1]
312571
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29/11/2021
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Approval date [1]
312571
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28/02/2022
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Ethics approval number [1]
312571
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81922
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Summary
Brief summary
Finding people with chronic liver disease and silent liver cirrhosis (scarring) who are at risk of liver failure and liver cancer is a critical public health issue. The AST-to-platelet ratio index (APRI) determines the risk of liver cirrhosis and is calculated using routine blood tests. In this study, we determine whether an innovative cirrhosis screening program of automated APRI calculation and provision of liver disease education information including a weblink for Fibroscan referral on routine pathology blood test results increases liver cirrhosis diagnosis and linkage to specialist care. We hypothesise that the inclusion of automated fibrosis scores will lead to an increased recognition of individual's at risk of significant fibrosis and improved linkage to care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Jessica Howell
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Address
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St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 9231 3580
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Fax
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Email
125134
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[email protected]
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Contact person for public queries
Name
125135
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A/Prof Jessica Howell
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Address
125135
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St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
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Country
125135
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Australia
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Phone
125135
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+61 3 9231 3580
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Fax
125135
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Email
125135
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[email protected]
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Contact person for scientific queries
Name
125136
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A/Prof Jessica Howell
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Address
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St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
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Country
125136
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Australia
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Phone
125136
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+61 3 9231 3580
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Fax
125136
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Email
125136
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Availability has not been approved by ethics committee
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18532
Study protocol
pending publication
18533
Ethical approval
385519-(Uploaded-08-03-2023-10-27-46)-Study-related document.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.
Download to PDF