Since her 40s, Lilly Lidot has received yearly mammograms. Her sister did not get regular checkups, so when her cancer was diagnosed it had already spread to her brain. Lilly's sister died in 2010.
When Lidot, now 62, received an invitation from UC San Diego Health to participate in the Women Informed to Screen Depending on Measures of Risk (WISDOM) clinical trial she immediately signed up. Its aim is to uncover whether annual mammograms are the best way to screen for breast cancer, or whether a more personalized approach -; driven by the data attached to each woman's genetic makeup, family history and risk factors -; could deliver better results.
"Scientific research is a great way to have the facts that determine why and how often women should get mammograms," said Lidot. "I know I'm going to get a mammogram regularly anyways, so I might as well be part of important research. The results will benefit woman-kind around the world and that's something I can get behind."
When and whether to get a mammogram has been an ongoing discussion in the health field. That is why the five University of California medical centers, including Moores Cancer Center at UC San Diego Health, joined together to recruit 100,000 women in California to be part of WISDOM.
"Screening guidelines for breast cancer have changed many times over recent years and seem to be in a constant state of flux," said Andrea Z. LaCroix, PhD, professor and chief of epidemiology in the department of Family Medicine and Public Health at University of California San Diego School of Medicine and co-principal investigator in the study. "The WISDOM trial's goal is to test annual screening versus a personalized schedule based on a woman's clinical and genetic risk factors for breast cancer. The study should determine which strategy produces the most benefit for women and the least harms."
To participate, women must be between 40 and 74 years old and not have had breast cancer. Women do not need to be a patient at UC Health medical centers. They can have their mammograms completed by their physician or they may go to a UC Health center.
The first step is for women to fill out an online questionnaire that covers health and family history. Each participant is then invited to be randomized (assigned by chance) to either the personalized or the annual screening arm of the study. However, if a participant has a strong preference, she is welcome to choose her own study arm. Women in the annual screening arm will have annual mammograms; those in the personalized arm will be assessed for their risk of developing breast cancer, and given a genetic test.
Those women assessed with the highest personal risk will receive recommendations to begin screening at an earlier age, have mammograms more often and continue screening until they are older. Those with the lowest risk will begin screening later, screen less frequently and stop screening earlier. No woman will be screened less often than the United States Preventive Services Task Force guidelines recommend.
Several insurance companies have opted to cover the cost of the genetic tests; for participants who do not have participating insurance coverage, the tests will be paid for with philanthropic funds.
The study is designed to minimize the incidence of false positive mammogram results, as well as of cancers detected between mammogram screenings or at later stages. Women with known high-risk genetic mutations will be screened according to National Comprehensive Cancer Network guidelines.
In addition to finding out if personalized screening is as safe as annual screening, the study will work to determine if it causes fewer adverse effects, such as unnecessary follow-up screenings, biopsies or other procedures, and whether women accept the approach. Personalized screening may identify genetic risk of breast cancer in women who were unaware that they carry a genetic mutation that increases their chance of developing breast cancer.
"If you don't have cancer in your family you may think it won't happen to you. You may think cancer happens to other people," said Lidot. "I was participating in walks that fundraised for breast cancer research 20 years ago, before I knew anyone had been treated for cancer. We just did it because we thought it was a good cause. Now I know that it's important to get a mammogram. Even if you don't want to be part of this study just get your mammogram."
WISDOM is the result of a five-year, $14.1 million grant from the Patient-Centered Outcomes Research Institute and is being conducted through the Athena Breast Health Network, a collaboration of the five UC Health medical centers to drive innovation in breast cancer prevention, screening and treatment.
"We want women to help us clarify mammogram guidelines and in the process learn about their own personal risk for breast cancer," said LaCroix. "Women need breast cancer screening programs that truly reduce their risk of dying from breast cancer and do not result in unnecessary procedures, stress, surgeries and other harms."