Using polygenic risk modification to improve breast cancer prevention: study protocol for the PRiMo multicentre randomised controlled trial Article Swipe
Simone McInerny
,
Lyon Mascarenhas
,
Tatiane Yanes
,
Lara Petelin
,
Georgia Chenevix‐Trench
,
Melissa C. Southey
,
Mary‐Anne Young
,
Paul A. James
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2024-087874
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2024-087874
Introduction Established personal and familial risk factors contribute collectively to a woman’s risk of breast or ovarian cancer. Existing clinical services offer genetic testing for pathogenic variants in high-risk genes to investigate these risks but recent information on the role of common genomic variants, in the form of a Polygenic Risk Score (PRS), has provided the potential to further personalise breast and ovarian cancer risk assessment. Data from cohort studies support the potential of an integrated risk assessment to improve targeted risk management but experience of this approach in clinical practice is limited. Methods and analysis The polygenic risk modification trial is an Australian multicentre prospective randomised controlled trial of integrated risk assessment including personal and family risk factors with inclusion of breast and ovarian PRS vs standard care. The study will enrol women, unaffected by cancer, undergoing predictive testing at a familial cancer clinic for a pathogenic variant in a known breast cancer (BC) or ovarian cancer (OC) predisposition gene ( BRCA1 , BRCA2 , PALB2 , CHEK2 , ATM , RAD51C , RAD51D ). Array-based genotyping will be used to generate breast cancer (313 SNP) and ovarian cancer (36 SNP) PRS. A suite of materials has been developed for the trial including an online portal for patient consent and questionnaires, and a clinician education programme to train healthcare providers in the use of integrated risk assessment. Long-term follow-up will evaluate differences in the assessed risk and management advice, patient risk management intentions and adherence, patient-reported experience and outcomes, and the health service implications of personalised risk assessment. Ethics and dissemination This study has been approved by the Human Research Ethics Committee of Peter MacCallum Cancer Centre and at all participating centres. Study findings will be disseminated via peer-reviewed publications and conference presentations, and directly to participants. Trial registration number ACTRN12621000009819.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2024-087874
- https://bmjopen.bmj.com/content/bmjopen/14/8/e087874.full.pdf
- OA Status
- gold
- Cited By
- 7
- References
- 51
- Related Works
- 10
- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4401368336Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1136/bmjopen-2024-087874Digital Object Identifier
- Title
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Using polygenic risk modification to improve breast cancer prevention: study protocol for the PRiMo multicentre randomised controlled trialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2024Year of publication
- Publication date
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2024-08-01Full publication date if available
- Authors
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Simone McInerny, Lyon Mascarenhas, Tatiane Yanes, Lara Petelin, Georgia Chenevix‐Trench, Melissa C. Southey, Mary‐Anne Young, Paul A. JamesList of authors in order
- Landing page
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https://doi.org/10.1136/bmjopen-2024-087874Publisher landing page
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https://bmjopen.bmj.com/content/bmjopen/14/8/e087874.full.pdfDirect link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://bmjopen.bmj.com/content/bmjopen/14/8/e087874.full.pdfDirect OA link when available
- Concepts
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Medicine, Breast cancer, Protocol (science), Randomized controlled trial, Cancer prevention, Alternative medicine, Cancer, Physical therapy, Family medicine, Oncology, Internal medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
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7Total citation count in OpenAlex
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2025: 7Per-year citation counts (last 5 years)
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51Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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