Trial Review

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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
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
Secondary ID [1] 309148 0
None
Universal Trial Number (UTN)
U1111-1289-4679
Trial acronym
CAPRISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
liver cirrhosis 329255 0
Condition category
Condition code
Oral and Gastrointestinal 326208 326208 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 326285 326285 0 0
Epidemiology
Public Health 326286 326286 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325596 0
Early detection / Screening
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.
Control group
Historical

Outcomes
Primary outcome [1] 334089 0
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.
Timepoint [1] 334089 0
At the conclusion of the study
Primary outcome [2] 334090 0
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.
Timepoint [2] 334090 0
At the conclusion of the study
Primary outcome [3] 334091 0
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
Timepoint [3] 334091 0
At the conclusion of study
Secondary outcome [1] 419313 0
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)
Timepoint [1] 419313 0
At the conclusion of study
Secondary outcome [2] 419314 0
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.
Timepoint [2] 419314 0
At the conclusion of study

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Blood tests performed during a hospital inpatient stay, defined by St Vincent’s Pathology records (blood collection site).

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100000
Accrual to date
78947
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313350 0
Other
Name [1] 313350 0
Gilead Sciences (Gilead Fellowship Research Grant)
Country [1] 313350 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Pde
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 315097 0
None
Name [1] 315097 0
Address [1] 315097 0
Country [1] 315097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312571 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 312571 0
41 Victoria Pde, Fitzroy VIC 3065
Ethics committee country [1] 312571 0
Australia
Date submitted for ethics approval [1] 312571 0
29/11/2021
Approval date [1] 312571 0
28/02/2022
Ethics approval number [1] 312571 0
81922

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125134 0
A/Prof Jessica Howell
Address 125134 0
St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
Country 125134 0
Australia
Phone 125134 0
+61 3 9231 3580
Fax 125134 0
Email 125134 0
jessica.howell@svha.org.au
Contact person for public queries
Name 125135 0
A/Prof Jessica Howell
Address 125135 0
St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
Country 125135 0
Australia
Phone 125135 0
+61 3 9231 3580
Fax 125135 0
Email 125135 0
jessica.howell@svha.org.au
Contact person for scientific queries
Name 125136 0
A/Prof Jessica Howell
Address 125136 0
St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
Country 125136 0
Australia
Phone 125136 0
+61 3 9231 3580
Fax 125136 0
Email 125136 0
jessica.howell@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability has not been approved by ethics committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18532Study protocolpending publication  
18533Ethical 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.