Personalized breast cancer screening based on individual risk factors
Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer (Wisdom Study)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100000 (estimated) |
| Ages | 30 Years to 74 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 11 sites (Birmingham, Alabama and 10 other locations) |
| Trial ID | NCT02620852 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 30 to 74 who reside in specific states or have coverage from a participating health plan.
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.
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 performed: Other studies have shown success with personalized screening approaches, indicating potential for meaningful advancements in breast cancer detection strategies.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 10 other locations
- 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)
- TopLine MD Alliance — Miami, Florida, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Louisiana State University — New Orleans, Louisiana, United States (Active_not_recruiting)
- Weill Cornell Medicine — New York, New York, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.