WISDOM Randomized Trial Comparing Risk-Based Versus Annual Breast Cancer Screening: Study Cohort Characteristics and Design

WISDOM Randomized Trial Comparing Risk-Based Versus Annual Breast Cancer Screening: Study Cohort Characteristics and Design | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article WISDOM Randomized Trial Comparing Risk-Based Versus Annual Breast Cancer Screening: Study Cohort Characteristics and Design Allison Fiscalini, Kelly Blum, Kirkpatrick Fergus, Robert A. Hiatt, and 38 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7665355/v2 This work is licensed under a CC BY 4.0 License Archived Versions: Posted Version 2 posted You are reading this latest preprint version Abstract The Women Informed to Screen Depending on Measures of risk (WISDOM) Study (NCT02620852) is pragmatic randomized controlled trial evaluating risk assessment to inform the age to start, frequency and modality of breast cancer screening and risk reduction. The WISDOM Study uses a preference-tolerant design, enabling women who decline randomization to self-select their screening arm. The risk-based arm included comprehensive breast cancer risk assessment using the Breast Cancer Surveillance Consortium (BCSC) model and genetics. From August 2016 – February 2023, WISDOM enrolled a large, diverse, nationwide cohort of 46,289 participants − 77% non-Hispanic (NH) White, 9% Hispanic, 6% (NH) Black, and 5% (NH) Asian; demographic diversity increased over time. Mean age at baseline was 54 years. 28,335 (61.2%) were randomized, while 89% of those who self-selected their screening arm chose risk-based screening. The preference-tolerant design captured real-world screening preferences while maintaining scientific rigor and demonstrated strong preference for risk-based screening. Randomized Controlled Trial Breast Cancer Screening Prevention Polygenic Risk Score Full Text Additional Declarations Competing interest reported. Olufunmilayo Olopade is co-founder and equity shareholder of CancerIQ, and Board Director of 54gene. Laura van ‘T Veer is a stockholder of Agendia and a consultant to Exai Bio Inc. Laura J. Esserman is a Medical Advisory Panel member for Blue Cross Blue Shield and has received consulting fees from UpToDate. The remaining authors declare no competing interests. Supplementary Files WISDOM.BaselineSupplementFINAL2025.12.05v2.pdf Cite Share Download PDF Archived Versions: Posted Version 2 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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