Clinical trial Recruiting at 9 sites Interventional Ages 30 to 74 Women only

Personalized breast cancer screening based on individual risk factors

Official title: Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer (Wisdom Study)

Run by University of California, San Francisco · NCT02620852 · Data updated 2026-11-12

This study is testing a personalized breast cancer screening method for women over 40 to see if it works better than standard yearly mammograms by using individual health and genetic information.

Quick facts

Study typeInterventional
Ages30 Years to 74 Years
SexWomen only
Enrollment100000 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations11 sites (Birmingham, Alabama and 10 other locations)
StatusRecruiting
StartedAugust 31, 2016
Main results expectedSeptember 30, 2029
Study endsSeptember 30, 2029
Registry record updatedSeptember 21, 2026
Trial IDNCT02620852 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are females aged 30 to 74 who reside in specific states or have coverage from a participating health plan.

Probably not a fit

Patients with a prior diagnosis of breast cancer or ductal carcinoma in situ, or those who have undergone prophylactic mastectomy, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a personalized approach to breast cancer screening by comparing traditional annual mammograms for women aged 40 and older with a more tailored screening strategy based on individual risk assessments. Participants will complete a health questionnaire and provide a saliva sample for genetic testing, which will inform their screening advice. The goal is to reduce unnecessary treatments and false-positive results while maintaining effective cancer detection rates. The study aims to address the ongoing debate regarding the effectiveness of current screening guidelines and explore the potential benefits of individualized screening.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and less stressful breast cancer screening for women, reducing unnecessary interventions.

How similar studies have gone: Other studies have shown success with personalized screening approaches, indicating potential for meaningful advancements in breast cancer detection strategies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Female\*
2. Age 30 years to 74 years old\*\*
3. Reside in the United States\*\*\*

NOTE\*: As of 2019, we are now enrolling all persons who identify as female, and will capture both their sex at birth and gender identity in the baseline survey.

NOTE\*\*: Eligibility from 2016 - October 2023 included ages 40-74 (WISDOM 1.0) and expanded to age 30 in October 2023 (WISDOM 2.0).

NOTE\*\*\*: As of 2019, recruitment is available nationwide. Original eligibility was limited to California, North Dakota, South Dakota, Iowa, Minnesota, Alabama, Louisiana, Illinois OR have coverage from a participating health plan.

Exclusion Criteria:

1. Prior Breast cancer or ductal carcinoma in situ (DCIS) diagnosis
2. Prior prophylactic bilateral mastectomy
3. Inability to provide consent
4. Non-English or Spanish proficiency (Spanish participation available: June 2019)

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • University of California Irvine
    Irvine, California, United States
    Recruiting
  • University of California Los Angeles
    Los Angeles, California, United States
    Recruiting
  • University of California Davis
    Sacramento, California, United States
    Recruiting
  • University of California San Diego
    San Diego, California, United States
    Recruiting
  • University of California San Francisco
    San Francisco, California, United States
    Recruiting
Show 5 more locations
  • TopLine MD Alliance
    Miami, Florida, United States
    Recruiting
  • University of Chicago
    Chicago, Illinois, United States
    Recruiting
  • Weill Cornell Medicine
    New York, New York, United States
    Recruiting
  • Louisiana State University
    New Orleans, Louisiana, United States
    Active not recruiting
  • Edith Sanford Breast Center
    Sioux Falls, South Dakota, United States
    Active not recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.