WISDOM randomized trial comparing risk-based versus annual breast cancer screening: study cohort characteristics and design
Year: 2026
Type: article
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 46,403 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. 28,372 (61%) 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.
Source: npj Breast Cancer
Authors: Allison Fiscalini, Kelly Blum, Kirkpatrick Fergus, Robert A. Hiatt, Arash Naeim, Andrea Kaster, Maren T. Scheuner, Laura J. van ‘t Veer, Andrea Z. LaCroix, Alexander D. Borowsky, Olufunmilayo I. Olopade, Hannah L. Park, James Esserman, Rachael Lancaster, Diane Heditsian, Susie Brain, Vivian Lee, Deborah L. Goodman, Katherine S. Ross, Neil Wenger, Barbara A. Parker, Lisa Madlensky, Jeffrey A. Tice, Yiwey Shieh, Elad Ziv, Vignesh A. Arasu, Hoda Anton-Culver, Celia P. Kaplan, Kim F. Rhoads, Kimberly Badal, Michael Hogarth, Antonia Petruse, Irene A. Soto, Katherine Leggat-Barr, Steffanie Goodman, Jennifer Atamer, Rita Ryu, Kelly Adduci, Jeffrey B. Matthews, Martin Eklund, The Athena/WISDOM Network Collaborators and Advocate Partners, Leah P. Sabacan, Laura Esserman
Institutions: University of California, San Francisco, University of California, Los Angeles, Sanford Health, San Francisco VA Health Care System, University of California San Diego, University of California, Davis, University of Chicago, University of California, Irvine, University of Alabama at Birmingham, Weill Cornell Medicine, Kaiser Permanente, Kaiser Permanente Northern California, Tufts University, Karolinska Institutet
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,790
OpenAlex ID: W4414830482