# Extending the Diversity, Reach, and Generalizability of the WISDOM Study

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2024 · $1,741,554

## Abstract

PROJECT SUMMARY/ABSTRACT
The WISDOM Study (Women Informed to Screen Depending on Measures of risk) is a
pragmatic trial comparing a personalized approach to breast cancer screening – in which the
intensity and modality of screening is dependent upon stratified personal risk -- against the gold
standard of annual screening. The goal is to determine whether a personalized approach is as
safe, less morbid, better accepted by women, encourages uptake of preventive interventions,
and is of higher health care value (better outcomes at less cost psychologically, physically, and
financially).
In this proposal `Expanding the WISDOM Study's Diversity, Reach, and Generalizability', we are
seeking support to expand the study to additional sites around the country to enhance
recruitment, improve study power and increase both the geographic and population diversity of
study participants. By doing so, our intention is to increase the generalizability of the study
results. Using a unique coverage with evidence progression model, we have secured insurance
coverage and outreach collaboration from multiple payers, giving us the opportunity to enroll
from an additional population of ~6 million women across multiple regions and varied ethnic and
socioeconomic backgrounds. The network of sites that this proposal will enable us to add will
allow us to create a collaborative group to continuously improve screening and learn who is at
risk for what kind of cancer.
The personalized screening arm includes a risk assessment based on family history, exposures,
breast density, co-morbidity and genetic predisposition (presence of mutations in the 9 genes
associated with screening and the combination of the small variation in inherited genes, the
single nucleotide polymorphisms, into a polygenic risk score or PRS). Importantly, the PRS
score is tailored to different ethnicities based on advances in the science of risk assessment,
allowing us to translate these important findings into practice. We are using an adaptive
approach in which the risk model is updated over the course of the trial as new information
emerges. The personalized approach yields an integrated risk score that allows us to assign an
age to start, an age to stop, a frequency of screening, and a modality for screening.
The R01 Specific Aims are to:
1. Open new clinical sites with experience enrolling targeted populations and use culturally
 targeted materials to increase the numbers in and diversity of the WISDOM study
population
2. Enhance trial enrollment and retention through national partnerships, centralized campaigns
 across the network and embedded analytics with real time feedback

## Key facts

- **NIH application ID:** 10798287
- **Project number:** 5R01CA237533-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** LAURA J ESSERMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,741,554
- **Award type:** 5
- **Project period:** 2020-03-01 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10798287

## Citation

> US National Institutes of Health, RePORTER application 10798287, Extending the Diversity, Reach, and Generalizability of the WISDOM Study (5R01CA237533-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10798287. Licensed CC0.

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