Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000873527p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2024
Date registered
17/07/2024
Date last updated
17/07/2024
Date data sharing statement initially provided
17/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The CASSOWARY (CAncer genomic riSk ScOres in primARY Care) Trial
Scientific title
The CASSOWARY (CAncer genomic riSk ScOres in primARY Care) Trial: a randomised controlled trial of the clinical utility and cost-effectiveness of a multi-cancer polygenic risk score in general practice
Secondary ID [1] 310857 0
N/A
Universal Trial Number (UTN)
Trial acronym
The CASSOWARY Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 331894 0
Condition category
Condition code
Cancer 328623 328623 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 328624 328624 0 0
Breast
Cancer 328625 328625 0 0
Prostate
Cancer 328626 328626 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a ‘complex intervention’ and contains several components. The main component is a polygenic risk score, with a post-test consultation (approximately 30 minutes in duration) to discuss the participant's personal risk of melanoma, colorectal, breast and prostate cancer with an associated risk report for the participant and their GP.

Participants will attend an appointment (approximately 30 minutes) with a trained researcher to complete consent, collect demographic details and complete a baseline questionnaire regarding family history of cancer and cancer screening activities.

Participants in the intervention group will provide a DNA sample using a saliva kit. They will receive the results of the polygenic risk score during a consultation with a research 3-4 weeks later. A polygenic risk score for each cancer will be generated from the presence or absence of each of the SNPs (consisting of those known to be associated with risk of the relevant cancer), using the most up-to-date relative risks of cancer for each DNA variant and the individual’s family history of cancer. Applying Australian age-sex incidence data, a 10-year absolute risk of each cancer will be calculated. Screening recommendations will be generated to correspond to NHMRC-endorsed national guidelines for each cancer. No participant will be recommended less screening than the current NHMRC-endorsed national guidelines. The reports are designed to alter screening and referral behaviours, with details for how participants can action their recommendations (e.g. contact details for BreastScreen Victoria to book a mammogram). Approximately 10% of these consultations will be audio recorded (involving participants who confirmed their consent to being audio recorded in their trial consent form) for quality control purposes.

A print-out report summarising the participant’s cancer risks and screening recommendations will be given to the participant and their GP to discuss. The GP will, as required, organise appropriate cancer screening. The risk report is designed to increase response efficacy for screening; a person’s belief that the behaviour will reduce their disease risk.
Intervention code [1] 327274 0
Early detection / Screening
Intervention code [2] 327275 0
Prevention
Intervention code [3] 327276 0
Behaviour
Comparator / control treatment
Participants randomised to the control group will receive an attention control brochure regarding ways to reduce their risk of cancer and during a consultation with a researcher. This brochure is based on the Cancer Council Victoria 2022 '7 ways to help prevent cancer' document.
Control group
Active

Outcomes
Primary outcome [1] 336424 0
The rate of risk-appropriate screening behaviours for colorectal, melanoma, breast and prostate cancer. The numerator is the count of risk-appropriate screening behaviours which were due and completed within 12 months post-delivery of the intervention or attention control and the denominator is the number of participants in each group.
Timepoint [1] 336424 0
12 months post delivery of the intervention or attention control
Secondary outcome [1] 436785 0
Impact of the intervention on over-screening: either an inappropriate test (e.g., colonoscopy in someone at average risk of colorectal cancer), commencing screening younger than recommended (e.g., PSA in a man in his forties at average risk of prostate cancer), or too frequent screening (e.g., annual mammograms in an average risk woman)
Timepoint [1] 436785 0
12 months post-delivery of the intervention or attention control
Secondary outcome [2] 436787 0
Perceived risk personal of colorectal cancer (absolute and comparative)
Timepoint [2] 436787 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [3] 436789 0
Perceived risk personal of melanoma (absolute and comparative)
Timepoint [3] 436789 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [4] 436791 0
(Biologically female participants only) Perceived risk personal of breast cancer (absolute and comparative)
Timepoint [4] 436791 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [5] 436792 0
(Biologically male participants only) Perceived risk personal of prostate cancer (absolute and comparative)
Timepoint [5] 436792 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [6] 436794 0
(Intervention participants only) Psychosocial impact of the genomic test result
Timepoint [6] 436794 0
1 month following delivery of the trial intervention
Secondary outcome [7] 436795 0
Cancer-specific anxiety
Timepoint [7] 436795 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [8] 436796 0
salience and coherence, response efficacy, cancer worries, social influence on/about cancer screening
Timepoint [8] 436796 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [9] 436797 0
Self-efficacy to complete colorectal cancer screening tests
Timepoint [9] 436797 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [10] 436798 0
Self-efficacy to complete melanoma cancer screening tests
Timepoint [10] 436798 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [11] 436799 0
(Biologically female participants only) Self-efficacy to complete breast cancer screening tests
Timepoint [11] 436799 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [12] 436800 0
(Biologically male participants only) Self-efficacy to complete prostate cancer screening tests
Timepoint [12] 436800 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [13] 436801 0
Intentions to perform colorectal cancer screening tests
Timepoint [13] 436801 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [14] 436802 0
Intentions to perform melanoma screening tests
Timepoint [14] 436802 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [15] 436803 0
(Biologically female participants only) Intentions to perform breast cancer screening tests
Timepoint [15] 436803 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [16] 436804 0
(Biologically male participants only) Intentions to perform prostate cancer screening tests in the next three months
Timepoint [16] 436804 0
Baseline, 1, 6 and 12 months post-delivery of the intervention or attention control
Secondary outcome [17] 436990 0
Clinical outcomes of screening tests for colorectal, melanoma, breast and prostate cancer
Timepoint [17] 436990 0
12 months post-delivery of the intervention or attention control
Secondary outcome [18] 436991 0
Clinical outcomes of screening tests for colorectal, melanoma, breast and prostate cancer
Timepoint [18] 436991 0
12 months post-delivery of the intervention or attention control
Secondary outcome [19] 436992 0
The rate of risk-appropriate screening behaviours for colorectal, melanoma, breast and prostate cancer. The numerator is the total count of risk-appropriate screening behaviours which were due and completed within 5 years post-delivery of the intervention or attention control and the denominator is the number of participants in each group.
Timepoint [19] 436992 0
5 years post-delivery of the intervention or attention control

Eligibility
Key inclusion criteria
•Are aged between 40 and 59 years
•Are able to read and write English and competent to give informed consent
•Are contactable over the next 12 months for trial follow-up
Minimum age
40 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
•Have been diagnosed with any of breast, prostate, colorectal cancer or melanoma;
•Have any alarm symptoms that are potentially indicative of any cancer:
Once or more and not investigated:
Blood in stool or urine
•For more than four weeks and not investigated:
Problems with urination
Diarrhoea
Unexplained weight loss
An unusual pain, lump or swelling anywhere in the body
A new or changed spot on the skin;
•Have a known genetic predisposition to any of the four cancers in question or, a first-/second-degree relative with a genetic predisposition and the participants has not had genetic testing themselves. This includes (but is not limited to) by a pathogenic variant in any of the following genes:
CRC: Lynch syndrome (MLH1, PMS2, MSH2, MSH6, EPCAM), familial adenomatous polyposis (APC);
BrCa: BRCA1, BRCA2, PALB2, ATM, CHEK2;
PrCa: BRCA1, BRCA2, HOXB13;
Melanoma: CDKN2A/p16.
•Have any health condition or illness that, in the opinion of the participant or researcher, would impact their appropriateness for cancer screening or their ability to participate

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation occurs following the recruitment and baseline data collection of a participant. Researchers involved in this process are blinded to the sequence of allocation as this is uploaded to the trial database randomisation module by a biostatistician removed from any participant-facing trial activities.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Baseline data will be entered into an online trial database prior to randomisation; participants will be randomly allocated 1:1 to intervention or control. The allocation sequence will be computer generated to ensure allocation concealment, sequentially within each stratum (general practice) using a biased-coin algorithm that will be embedded within the online database.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
2/09/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315113 0
Government body
Name [1] 315113 0
The Medical Research Future Fund (MRFF), Department of Health and Aged Care
Country [1] 315113 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 317130 0
None
Name [1] 317130 0
Address [1] 317130 0
Country [1] 317130 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314051 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 314051 0
Ethics committee country [1] 314051 0
Australia
Date submitted for ethics approval [1] 314051 0
14/05/2024
Approval date [1] 314051 0
Ethics approval number [1] 314051 0

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

Contacts
Principal investigator
Name 130242 0
Prof Jon Emery
Address 130242 0
University of Melbourne Centre for Cancer Research, Level 10, Victorian Comprehensive Cancer Centre 305 Grattan St Melbourne Victoria 3000
Country 130242 0
Australia
Phone 130242 0
+61 03 85597189
Fax 130242 0
Email 130242 0
[email protected]
Contact person for public queries
Name 130243 0
Dr Sibel Saya
Address 130243 0
University of Melbourne Centre for Cancer Research, Level 10, Victorian Comprehensive Cancer Centre 305 Grattan St Melbourne Victoria 3000
Country 130243 0
Australia
Phone 130243 0
+61 03 85597189
Fax 130243 0
Email 130243 0
[email protected]
Contact person for scientific queries
Name 130244 0
Dr Sibel Saya
Address 130244 0
University of Melbourne Centre for Cancer Research, Level 10, Victorian Comprehensive Cancer Centre 305 Grattan St Melbourne Victoria 3000
Country 130244 0
Australia
Phone 130244 0
+61 03 85597189
Fax 130244 0
Email 130244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.