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 type | Interventional |
|---|---|
| Ages | 30 Years to 74 Years |
| Sex | Women only |
| Enrollment | 100000 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 11 sites (Birmingham, Alabama and 10 other locations) |
| Status | Recruiting |
| Started | August 31, 2016 |
| Main results expected | September 30, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT02620852 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
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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
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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
- Principal investigator: Laura Esserman, MD, MBA — University of California, San Francisco
- Study coordinator: Allison Fiscalini, MPH
- Email: allison.stoverfiscalini@ucsf.edu
- Phone: (415) 476-0267
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.