Addressing overdiagnosis and overtreatment in cancer: a prescription for change.
Laura J Esserman, Ian M Thompson, Brian Reid...
https://pubmed.ncbi.nlm.nih.gov/24807866Actively Recruiting
Phase Not Applicable
Age: 30Years - 74Years
FEMALE
Healthy Volunteers
ID02620852
Enabling a Paradigm Shift: A Preference-Tolerant Randomized Controlled Trial of Personalized versus Annual Screening for Breast Cancer (Wisdom Study)
Led by University of California, San Francisco · Updated on 2025-11-25
100000
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates breast cancer screening by comparing the traditional annual mammogram approach to a personalized, risk-based screening schedule. It focuses on women aged 30 to 74 and aims to improve screening by considering personal risk factors such as family and medical history, breast density, and genetic markers. This approach seeks to reduce false positives, anxiety, and unnecessary biopsies while maintaining effective cancer detection. Participants are assigned to one of two groups: the annual screening arm, where women receive yearly mammograms and basic risk assessment advice; and the risk-based arm, where women undergo a comprehensive risk evaluation including genetic testing and receive personalized screening recommendations for when to start, stop, and how often to screen. Women in the risk-based arm provide saliva samples for testing nine genes and a panel of genetic variants related to breast cancer risk. During the study, participants complete health questionnaires and provide samples for genetic analysis if in the risk-based group. Researchers monitor outcomes such as late-stage cancer incidence and biopsy rates over a minimum of five years. Other measures include rates of cancer stages, imaging, chemoprevention use, anxiety, and adherence to screening schedules. The study aims to provide a clearer understanding of personalized screening benefits and risks while continuing follow-up through 2026.
CONDITIONS
Brief Title
Women Informed to Screen Depending on Measures of Risk (Wisdom Study)
Who Can Participate
Age: 30Years - 74Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Identify as female
- Age between 30 and 74 years old
- Live in the United States
You will not qualify if you...
- Prior diagnosis of breast cancer or ductal carcinoma in situ (DCIS)
- Previous preventive bilateral mastectomy
- Unable to give consent
- Not proficient in English or Spanish (Spanish participation available starting June 2019)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Risk Assessment and Sample Collection
Duration - Initial assessment period before screening recommendations
Participants complete a health questionnaire and provide a saliva sample for genetic testing to assess breast cancer risk.
1 visit (in-person)
Screening
Duration - Up to 5 years or more depending on individual screening schedule
Participants receive screening schedule recommendations based on either a basic or comprehensive risk assessment depending on their study arm. Women in the annual arm receive annual mammograms; women in the risk-based arm receive personalized screening schedules tailored to their individual risk.
Screening visits scheduled according to assigned screening frequency
Long-term Monitoring
Duration - Up to 5 years (minimum) after initial screening
Participants are monitored for breast cancer outcomes and adherence to their assigned screening schedule for the duration of the study.
Ongoing follow-up contacts and assessments as per study protocol
Trial Site Locations
Total: 11 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California Irvine
Irvine, California, United States, 92618
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
5
University of California San Diego
San Diego, California, United States, 92093
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
7
TopLine MD Alliance
Miami, Florida, United States, 33173
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
Louisiana State University
New Orleans, Louisiana, United States, 70112
Active, Not Recruiting
10
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
11
Edith Sanford Breast Center
Sioux Falls, South Dakota, United States, 57117
Active, Not Recruiting
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Research Team
A
Allison Fiscalini, MPH
J
Jennifer Atamer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Published Research Related To This Trial
Validation studies for models projecting the risk of invasive and total breast cancer incidence.
J P Costantino, M H Gail, D Pee...
https://pubmed.ncbi.nlm.nih.gov/10491430Determining carrier probabilities for breast cancer-susceptibility genes BRCA1 and BRCA2.
G Parmigiani, D Berry, O Aguilar
https://pubmed.ncbi.nlm.nih.gov/9443863A breast cancer prediction model incorporating familial and personal risk factors.
Jonathan Tyrer, Stephen W Duffy, Jack Cuzick
https://pubmed.ncbi.nlm.nih.gov/15057881Risk models used to counsel women for breast and ovarian cancer: a guide for clinicians.
E B Claus
https://pubmed.ncbi.nlm.nih.gov/14574179Pilot trial of a computerized decision aid for breast cancer prevention.
Elissa M Ozanne, Caroline Annis, Kelly Adduci...
https://pubmed.ncbi.nlm.nih.gov/17319855Breast cancer risk prediction and individualised screening based on common genetic variation and breast density measurement.
Hatef Darabi, Kamila Czene, Wanting Zhao...
https://pubmed.ncbi.nlm.nih.gov/22314178Germline Pathogenic Variants Among Women Without a History of Breast Cancer: A Secondary Analysis of the WISDOM Randomized Clinical Trial.
Kirkpatrick B Fergus, Katherine S Ross, Maren T Scheuner...
https://pubmed.ncbi.nlm.nih.gov/41385723Risk-Based vs Annual Breast Cancer Screening: The WISDOM Randomized Clinical Trial.
Laura J Esserman, Allison S Fiscalini, Arash Naeim...
https://pubmed.ncbi.nlm.nih.gov/41385349Integrating breast cancer polygenic risk scores at scale in the WISDOM Study: a national randomized personalized screening trial.
Kirkpatrick B Fergus, Rachel S Heise, Lisa Madlensky...
https://pubmed.ncbi.nlm.nih.gov/40877879