Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Women Informed to Screen Depending on Measures of Risk (Wisdom Study)
NCT02620852 · View on ClinicalTrials.gov ↗
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
Conditions Studied
Interventions
- OTHER Complete a health questionnaire
- DEVICE Provide a saliva sample for genetic testing
- OTHER Screening advice based on a comprehensive risk assessment
- OTHER Screening advice based on a basic risk assessment
Study Locations (11)
California
- University of California Irvine — Irvine
- University of California Los Angeles — Los Angeles
- University of California Davis — Sacramento
- University of California San Diego — San Diego
- University of California San Francisco — San Francisco
Alabama
- University of Alabama at Birmingham — Birmingham
Florida
- TopLine MD Alliance — Miami
Illinois
- University of Chicago — Chicago
Louisiana
- Louisiana State University — New Orleans
New York
- Weill Cornell Medicine — New York
South Dakota
- Edith Sanford Breast Center — Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100,000 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02620852
The ClinicalTrials.gov registry entry for NCT02620852 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Complete a health questionnaire is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02620852 reports 11 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02620852 about?
NCT02620852 is a clinical study titled "Women Informed to Screen Depending on Measures of Risk (Wisdom Study)". 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 whe...
What is the current status of trial NCT02620852?
This trial is currently recruiting. It is a NA study. The enrollment target is 100,000 participants. The study started on 2016-08-31. Estimated completion is 2026-09-01.
What conditions does trial NCT02620852 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Cancer Screening, Breast Carcinoma in Situ. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02620852?
The interventions under investigation include: Complete a health questionnaire (OTHER), Provide a saliva sample for genetic testing (DEVICE), Screening advice based on a comprehensive risk assessment (OTHER), Screening advice based on a basic risk assessment (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02620852?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02620852 being conducted?
This trial has 11 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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