Discover What DNA Reveals About Your Breast Health
Update: WholeMe will be closing registration for new participants on December 16th.
The next phase of WholeMe genomic testing is here to help women feel informed about their breast cancer risk. AdventHealth will be partnering with Helix, a population genomics company, and Sema4, a patient-centered health intelligence company, to deliver more comprehensive breast cancer DNA test results.
This new study will enroll participants as they are scheduling their annual mammography appointments (at a participating site) and provide a breast cancer risk assessment to all participants.
If you choose to participate, your assessment will be given before your mammogram appointment.
Those at high risk will receive a clinical referral to an AdventHealth high-risk clinic and no further study activities are required.
Those at low/average risk would have no further study activities.
Those at moderate risk will be asked to provide a saliva sample for genetic testing during their mammogram appointment.
We're excited to inform you that the AdventHealth WholeMe research study is evolving! In this new chapter, AdventHealth will be partnering with Sema4, a patient-centered health intelligence company, to deliver even more comprehensive DNA test results.
As part of your WholeMe participation and consent, interpretations for breast and ovarian cancers will be completed. A full list of genes can be found below.
You'll have access to a care navigator who will assist you with the next steps. If you have a positive result in one of the genes being tested, you may be asked to complete a series of follow-up appointments, including:
A confirmatory genetic test with Sema4: a new saliva kit will be sent directly to your home with instructions for providing your sample and mailing it back.
A genetic counseling session with Sema4: this can be scheduled directly with Sema4 through their patient portal and is done as a virtual visit.
An appointment with one of AdventHealth's medical geneticists: a care navigator will assist with scheduling this follow-up appointment.
We recommend creating an AdventHealth account so you can access your results as soon as they are available. You can register for an account here.
If you have any questions, please reach out to the WholeMe Research team via email at [email protected].
Whole Me Breast Cancer Genes
This study will look at the following hereditary breast cancer genes that may indicate increased risk:
ATM
BARD1
BRCA1
BRCA2
CDH1
CHEK2
NF1
PALB2
PTEN
STK11
TP5
Upcoming Study Sites
The WholeMe study will be enrolling potential participants who schedule at the following locations:
Dates for Enrollment
Locations
May 1 – June 29, 2022
AdventHealth Imaging Center Princeton, AdventHealth Winter Park
July 1 – August 31, 2022
AdventHealth Imaging Center Lake Mary, AdventHealth Apopka
September 1 – October 31, 2022
AdventHealth Imaging Center Winter Garden, AdventHealth Celebration
November 1 – December 31, 2022
AdventHealth Imaging Center Princeton, AdventHealth Kissimmee
If you’re interested in enrolling in WholeMe, click below to complete the form and our study team will be in touch.
With Genomics, your doctor can truly personalize your health care as well as help prevent, diagnose and treat serious health risks.
Resources
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Whether you've received a new diagnosis or are looking for more support, we have a variety of resources available to you. Learn more about some of the services we offer through our AdventHealth Cancer Institute.
What if doctors could uncover your risk for disease and help you prevent it? Or determine whether a therapy or dose of medicine will be effective for your specific health needs? What if your health care plan was based on a sample size of 1 – just you?
With genomic profiles, physicians and researchers can determine with unprecedented accuracy if someone is at risk for cancer, heart disease and other conditions. From disease prevention to diagnosis to treatment, genomics is the future of medicine and will be an essential component of all health care.
In 2019, we began laying the foundation for our comprehensive program — AdventHealth Genomics and Personalized Health — which will ultimately provide comprehensive genomics testing, analysis, interpretation and genetic counseling services.
When it comes to treating the whole person, our genomics program will deliver on the renewed focus we promised during the launch of our new brand, AdventHealth. We believe personalized medicine that focuses on the whole person is superior health care and nothing is more personal than your DNA.
At AdventHealth, we believe knowledge is power.
Frequently Asked Questions
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WholeMe is a first-of-its-kind DNA study in Florida that will empower consumers with potentially lifesaving information through personalized genomic insights. This new study will allow participants to assess their breast cancer risk incorporated into their annual screening mammography. Those with moderate risk will have the opportunity to receive genetic testing for the genes linked to breast cancer.
What if a participant doesn’t have moderate risk?
Only those with moderate risk will receive genetic testing as part of the WholeMe study. Those who are assessed to be high risk would receive a referral to the AdventHealth genomics clinic for additional testing/screening. Those assessed to be low- or average-risk will have no additional study activities in WholeMe.
Why are we doing this?
From disease prevention to diagnosis to treatment, genomics is the future of medicine. Genomics will be an essential component of health care not just for the individual, but for our greater community as we focus on wellness and preventive care. The implications of genomics programs are significant for today’s patients, and importantly, the future of Florida’s health. WholeMe is an important component in our genomics program, and the study will:
Advance screening for breast cancer
Engage the community an increase their awareness of genetics and genomics in their health
Learn how patients respond and learn if the information influences their health decisions
Determine if knowledge is power for patients
What are we evaluating?
We will evaluate the DNA of participants who have moderate risk for breast cancer to determine if they have any genes linked to breast cancer.
Who can join the study?
Adults who are 40 or older, asymptomatic and are scheduled to receive their annual mammogram during the enrollment period. Enrollment is expected to begin in May 2022. For information, visit WholeMeFlorida.com.
What’s breast cancer?
Breast cancer is the most common cancer in women with more than 1.7 million cases diagnosed annually worldwide. Early diagnosis can come from mammography screening, genetic testing or both. Knowing if you have an increased risk of breast cancer would lead to additional screening tools or screening more often, which can lead to early diagnosis.
If I have breast cancer, could I pass this on to my children?
If you have genetic markers for breast cancer, each of your children will have a 50 percent chance of having it.
What about men who have genetic markers for breast cancer?
Men can also get breast cancer, although it is rarer in men. Men with genetic markers for breast cancer are also at a higher risk of developing prostate cancer, melanoma, and pancreatic cancer. According to the National Breast Cancer Foundation, men can also pass the markers to their children.
If I have breast cancer, can I be kicked off my health insurance, life insurance, or not be approved for either in the future?
In the unlikely event there is an unintended disclosure of information that can be used to identify you, it can affect your insurability, family relationships or other legal rights. You should know that there are laws in place to prevent this from taking place. A federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans and most employers to discriminate against you based on your genetic information. GINA does not apply to life insurance or disability insurance. Please ask the study investigator or study staff if you would like to know more about how your information will be protected while you are in this study.
If I have breast cancer, can my children be denied medical or insurance coverage?
Your family is protected by the Genetic Information Nondiscrimination Act (GINA).
Is this information incorporated into my medical record?
Not automatically, as WholeMe is a research study conducted outside your standard health care. However, should a participant take the information to their provider or seek care as a result of this genetic results, it can be incorporated into their record.
How long will the study last?
For those with high or low/average risk, the study ends once the participant is notified of those findings. For those with moderate risk, the initial genetic testing will take approximately 2 months to return.
Is there any cost to the consumer?
Participation in the research study is at no cost to participants. Participants will receive results of the breast cancer screening.
What is a consent form? Why is it necessary?
A consent form is a legal document provided to you as a research participant. The purpose of the consent form is to provide you with a clear understanding of the scope of the research, your role, your rights and any risks that may be involved while participating in a research study. After you sign the study’s consent form, a copy will be emailed to you to save for your records.
Can I choose to participate in the study?
Yes. Participation in this study is voluntary. You can choose not to take part. You can agree to take part and later change your mind. You can ask all the questions you want before you decide; your decision will not be held against you. Study participants may also choose to discontinue their participation at any time.
Who has access to my information?
As part of the study, the following organizations and people may have access to information about you: AdventHealth Orlando, Helix, and Sema4.
How is my information protected?
Study data will be stored in a confidential data repository that meets the HIPAA security standards and stored in accordance with applicable local, state, and federal laws. Individual records will be assigned a confidential ID number and will be separated from your personally identifiable information (e.g. name, address, phone number).
We will protect your personal information. There are laws that help us keep your information private. These laws say that some people can look at your information, for example IRB members and some people who work for AdventHealth might look at it. Only people who need to see your information may look at it. For example, AdventHealth care navigator will need to see your breast cancer test results in order to assist you with your health care needs.
What if I change my mind and want to withdraw?
You may cancel your permission to participate in this research at any time. You do this by sending written notice to the study investigator. When you cancel your permission, no new information about you will be gathered. Information that has already been gathered may still be used to support the WholeMe Research study. Your study cancellation will not affect your relationships with Helix.
What if I have general research questions about this research study?
You can contact the study investigator, Rebecca Essner, PhD, at [email protected] with additional research questions.
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