Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000007437p
Ethics application status
Submitted, not yet approved
Date submitted
5/12/2024
Date registered
7/01/2025
Date last updated
30/03/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
RoBiN (Risk of Breast Neoplasia): An acceptability and feasibility study of personalised screening.
Scientific title
RoBiN (Risk of Breast Neoplasia): An acceptability and feasibility study of personalised risk-based breast cancer screening in women aged 40 to 59 years.
Secondary ID [1] 313520 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RoBiN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 335971 0
Condition category
Condition code
Human Genetics and Inherited Disorders 332560 332560 0 0
Other human genetics and inherited disorders
Public Health 332558 332558 0 0
Health service research
Cancer 332559 332559 0 0
Breast
Public Health 332561 332561 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention incorporates a multifactorial risk assessment which incorporates major known breast cancer risk factors (family history, mammographic breast density [MBD], and a polygenic risk score [PRS]) to tailor subsequent screening recommendations based on the individual’s personal risk of developing breast cancer as an alternative to the current population-based age-stratified approach.

RoBiN utilises the validated BRISK risk prediction model, which does not require the collection of complex pedigree and medical history data unlike some other models (e.g. Tyrer-Cuzick and BOADICEA) thereby easing barriers to implementation. Women attending the BreastScreen Victoria (BSV) Burgundy Street clinic for a screening mammogram will be invited into the study and consented by a University of Melbourne (UoM) researcher at the clinic 30 minutes ahead of the scheduled appointment. At this appointment (baseline), the researcher will discuss the use of multifactorial risk assessments which incorporates family history, MBD and a genomic test to calculate a PRS. This discussion will include information about MBD, the genomic test, its potential implications for each participant and their recommended cancer screening. The participant will then provide a painless, non-invasive DNA sample using the ORAcollect DNA kit. This is an easy-to-use oral DNA collection kit allows for self or assisted buccal swab, which sample of cells from the inside of the mouth (cheek). DNA collected will be used to calculate a breast cancer PRS. The baseline appointment will take approximately 30 minutes to complete, following which the participant will continue to attend their screening mammogram as scheduled.

Clinical and genomic risk factors will be combined to calculate 10-year and lifetime risk of breast cancer using the BRISK model. The calculated risk will be mapped onto risk categories defined by Cancer Australia and used to tailor additional imaging tests and subsequent breast cancer screening. Screening recommendations will be generated to correspond to Cancer Australia’s position statement on the early detection of breast cancer in asymptomatic women. No participant will be recommended less screening than the current national guidelines provided by The Royal Australian College of General Practitioners (RACGP). Women with high MBD, irrespective of multifactorial breast cancer risk will be provided with additional imaging recommendations.

Participants and a nominated general practitioner (GP) or practice clinic will receive a risk report 3-4 weeks after study consent summarising their breast cancer risk, recommendations for any additional imaging test or changes to frequency of subsequent screening. Allowing the participant and GP to discuss any concerns and decide on a screening schedule appropriate for the participant. A study genetic counsellor will be available to discuss any concerns as required. The GP will (if required) be asked to organise appropriate referral based on study recommendations.

The decision to take up any additional imaging test recommended is at the discretion of the GP and the participant. If participants choose to complete additional imaging this can be accessed via Imaging Associates at no cost to the participants. Adherence to study recommendations based on the risk calculated as a part of the study intervention is not otherwise monitored, changes to screening behaviour is outside the scope of this pilot study. Participants will be contacted following the risk report to complete a brief questionnaire to measure acceptability and psychosocial outcomes.
Intervention code [1] 330107 0
Behaviour
Intervention code [2] 330105 0
Early detection / Screening
Intervention code [3] 330106 0
Prevention
Comparator / control treatment
No control treatment, All participants will be offered a multifactorial risk assessment which incorporates major known breast cancer risk factors, this will be used to tailor subsequent recommendations based on the individual’s personal risk of developing breast cancer as an alternative to the current population-based age-stratified approach.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340079 0
Feasibility of offering risk-based screening recommendations which incorporates MBD and PRS to women aged 40-59 attending BreastScreen Victoria.
Timepoint [1] 340079 0
The primary endpoint will be captured upon conclusion of the study.
Primary outcome [2] 340078 0
Acceptability of offering risk-based screening recommendations which incorporates MBD and PRS to women aged 40-59 attending BreastScreen Victoria.
Timepoint [2] 340078 0
The primary endpoint will be captured within 6 months post-receipt of the risk report.
Primary outcome [3] 340170 0
Feasibility of delivery (risk reporting, organising supplemental screening etc) will be evaluated through semi-structured interviews with participants, GPs and BreastScreen Victoria staff to examine the practicality of implementing this study within BreastScreen Victoria.
Timepoint [3] 340170 0
The primary endpoint will be captured upon conclusion of the study.
Secondary outcome [1] 442570 0
Breast cancer specific anxiety.
Timepoint [1] 442570 0
Baseline, 1 and 6 months post-receipt of risk report.
Secondary outcome [2] 442586 0
Willingness to pay for DNA screening.
Timepoint [2] 442586 0
Baseline and 6 months post-receipt of risk report.
Secondary outcome [3] 442576 0
Uptake and completion of additional supplemental screening or imaging during the study intervention. This will be assessed as a composite outcome.
Timepoint [3] 442576 0
1 and 6 months post-receipt of risk report.
Secondary outcome [4] 442571 0
Perceived personal risk of developing breast cancer.
Timepoint [4] 442571 0
Baseline, 1 and 6 months post-receipt of risk report.
Secondary outcome [5] 442575 0
Knowledge of breast density.
Timepoint [5] 442575 0
Baseline and 1 month post-receipt of risk report.
Secondary outcome [6] 442574 0
Impact of result disclosure after genomic testing.
Timepoint [6] 442574 0
1 month post-receipt of risk report.

Eligibility
Key inclusion criteria
Potential participants are those recruited at the BSV Burgundy Street clinic ahead of their scheduled mammogram, who meet all the following criteria:

- Women aged 40-59 years
- Able to read and write in English and competent to give informed consent
- Contactable over the next 7 months for the study follow up
Minimum age
40 Years
Maximum age
59 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have any of following criteria, which interfere with study outcomes are ineligible to take part in this study:

- Women who have been diagnosed with breast cancer or have symptoms that are potentially indicative of breast cancer
- A known pathogenic genetic variant that places them at higher risk of breast cancer (e.g. BRCA1, BRCA2, PALB2, ATM, CHEK2)
- Have previously undertaken genetic testing (does not include services such as 23andMe®, AncestryDNA®, EasyDNA or similar)
- A 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 in the study

Study design
Purpose of the study
Prevention
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
Acceptability, measured through three 5-point Likert scales will be used to assess attitude, comfort, and willingness to take part in breast cancer risk stratified screening with dichotomized responses (i.e. “yes, definitely/yes, probably”). Based on previous studies (63% response rate) descriptive statistics can be used to present the characteristics of the study sample and to report proportions of participants according to each dichotomized primary outcome variable. The sample size of 150 women with an approximate response rate of 63%, is pragmatic and adequate for evaluating the acceptability and feasibility of this approach. The feasibility of delivery will include recruitment rates, workflow integration, resource requirements, data management and privacy considerations, training needs to examine the practicality of implementing this study approach within the existing BreastScreen Victoria program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2025
Actual
Date of last participant enrolment
Anticipated
24/09/2025
Actual
Date of last data collection
Anticipated
24/03/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43473 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 317972 0
Government body
Name [1] 317972 0
National Health and Medical Research Council
Country [1] 317972 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320327 0
None
Name [1] 320327 0
Address [1] 320327 0
Country [1] 320327 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316642 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316642 0
Ethics committee country [1] 316642 0
Australia
Date submitted for ethics approval [1] 316642 0
14/03/2025
Approval date [1] 316642 0
Ethics approval number [1] 316642 0

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

Contacts
Principal investigator
Name 138510 0
Prof Jon Emery
Address 138510 0
University of Melbourne Centre for Cancer Research, Level 10, Victorian Comprehensive Cancer Centre 305 Grattan St Melbourne Victoria 3000
Country 138510 0
Australia
Phone 138510 0
+61 3 85597044
Fax 138510 0
Email 138510 0
[email protected]
Contact person for public queries
Name 138511 0
Dr Dulashi (Anna) Withanage Dona
Address 138511 0
University of Melbourne Centre for Cancer Research, Level 10, Victorian Comprehensive Cancer Centre 305 Grattan St Melbourne Victoria 3000
Country 138511 0
Australia
Phone 138511 0
+61 3 85597044
Fax 138511 0
Email 138511 0
[email protected]
Contact person for scientific queries
Name 138512 0
Dr Dulashi (Anna) Withanage Dona
Address 138512 0
University of Melbourne Centre for Cancer Research, Level 10, Victorian Comprehensive Cancer Centre 305 Grattan St Melbourne Victoria 3000
Country 138512 0
Australia
Phone 138512 0
+61 3 85597044
Fax 138512 0
Email 138512 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Due to the confidential nature of the data collected in this study, individual participant data for this study will not be made available including data dictionaries.



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.