Women Informed to Screen Depending on Measures of Risk (Wisdom Study)

Summary

Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis."

The WISDOM 1.0 study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive.

For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines.

If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.

Starting in Spring 2023, WISDOM's design shifted to remove the randomized option, but will continue with the preference/self-selection option for participation (WISDOM 2.0). Participants will therefore continue to choose their study arm (Personalized or Annual) rather than have the option to be randomized. This study design change was made after review of the WISDOM 1.0 data by an independent monitoring committee, which indicates that personalized screening does not cause harm. WISDOM 2.0 has also lowered the eligibility to ages 30-74. Women ages 30-39 will only be offered to join the Personalized Arm.

Conditions

• Breast Cancer Screening
• Breast Carcinoma in Situ
• Breast Cancer

Interventions

OTHER

Complete a health questionnaire

Complete a health history questionnaire.

DEVICE

Provide a saliva sample for genetic testing

Provide a saliva sample for testing of 9 genes and a panel of single nucleotide polymorphisms (SNPs) that influence breast cancer risk

OTHER

Screening advice based on a comprehensive risk assessment

Receive a screening schedule recommendation

OTHER

Screening advice based on a basic risk assessment

Receive a screening schedule recommendation

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Robert Wood Johnson Foundation

  collaborator OTHER

• Color Genomics, Inc.

  collaborator INDUSTRY

• Salesforce

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• Safeway Foundation

  collaborator UNKNOWN

• United States Department of Defense

  collaborator FED

• Breast Cancer Research Foundation

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Laura Esserman, MD, MBA · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

74 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2026-09-01

Completion

2026-09-01

FDA Device

Yes

Countries

• United States

Study Locations