The WISDOM study represents a groundbreaking effort to determine the optimal guidelines for breast cancer screening and now seeks qualifying women across the country that would like to contribute to improving breast cancer screening and prevention. WISDOM was recently expanded nation-wide to offer women regardless of where they live, where they receive healthcare or health insurance type the opportunity to engage and participate in groundbreaking research and in the process contribute to the ongoing improvement of breast cancer screening standards in America.
Officially titled “Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer” the study began in 2016 and concludes December 2020. The study sponsors seek to sign up 100,000 participants. The primary sponsors include the University of California, San Francisco, with collaborative sponsors including Patient-Centered Outcomes Research Institute, Robert Wood Johnson Foundation, Color Genomics, Inc., and Salesforce. The world’s largest medical evidence network, Life Image, is also contributing to the study as well as Mammosphere, a patient engagement platform for breast health.
The study takes on breast screening as today 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.
WISDOM needs participants to join the clinical study to test which approach to women’s breast screening is better. The sponsors seek to understand if all women need to get a mammograph every year. Or is it better to personalize how often women should be screened based on their individual risk. The goal is to improve the overall standard of care factoring in the personalization of health care based on rapidly expanding scientific knowledge.
How it Works
There are two groups of women in the study. The annual screening group and the personalized screening group. Regardless of group, the participant receives excellent. And no study participant is advised to be screened less frequently than the current recommended guidelines of the U.S. preventative services task force. If the participant is in the annual group, they are asked to get a mammogram every year starting at 40. This has been the standard for the past 30 years.
If the participant is placed in the personalized group, they are assigned their own personal own personal screening scheduled base on their medical history, family health history, lifestyle and genes. Some women in this group are advised to get a mammogram every year. Some more frequently and some less frequently. Women in high risk for breast cancer in either study group may be offered additional services. Women are randomly placed in one of the groups.
It’s all about Risk
This 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. Again, no woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines.
If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.
Original sites included University of California, Irvine, University of California, Los Angeles, University of California, Davis, University of California, San Diego and the sponsor—University of California, San Francisco as well as Edith Sanford Breast Center in South Dakota. Based on recent press activity that has expanded to include sites such as Summit Medical Group in New Jersey.
The Life Image Partnership
Life Image has joined the study—they were not included as a collaborator in the original ClinicalTrials.gov account. Apparently, the recent press release is associated with World Cancer Day and some press exposure to drive more participation and exposure to Life Image. They are the world’s largest medical exchange network specializing in diagnostic images. It is supporting the WISDOM study by offering participants Mammosphere, an electronic personal health app that enables women to securely request, store, and share their breast health history (including mammogram images) with the study of their healthcare providers. Founded in 2008, they have spent the last decade building an interoperable network ecosystem working to connect hospitals, biopharma sponsors, and telemedicine companies, practicing physicians and patients with medical imaging machines, storage databases and electronic health records. They report that they have over 1,500 facilities in the U.S. and 50,000 globally as well as 8 of the top 10 U.S. hospitals. Life Image is led by Matthew Michela.
Mammosphere was actually created by Dr. Kathryn Pearson Peyton who merged the venture with Life Image in 2016. Dr. Peyton had a personal connection to combatting cancer as several women in her family, including her mother and her own bilateral mastectomy, were impacted by breast cancer as reported in HealthIT Analytics.
About the WISDOM Study
WISDOM is a five-year longitudinal study that compares two different approaches to breast cancer screening – annual mammography vs. a personalized, risk-based approach. The goal of the study is to determine whether personalized screening is more effective than annual screening. The personalized screening approach will take multiple risk factors into consideration, including genetic markers, to determine the most effective screening frequency and modality for an individual. Over time, we can learn which risk factors are most important and continue to improve our screening recommendations accordingly.
Laura Esserman, MD, UCSF
Call to Action: Interested in contributing to this important effort? See information about signing up see the link.