Join us and help change the face of medicine
How Do I Participate?
OneDukeGen started in 2023 and will go until at least 2029. Eligible patients will receive an invitation to join the study through their Duke My Health (previously Duke MyChart) portal. We are currently inviting Duke patients who have certain medical diagnoses that researchers want to learn more about. Check your Duke My Health portal to see if you have received an invitation!
Your invitation to join OneDukeGen will include information about the study and a link to the study consent form. The consent form contains all of the information about the study and requires your signature at the end of the form. As part of the study, participants will be asked to provide a blood or saliva sample and complete surveys, which may include questions about you and your family’s medical history and your opinions about genetic testing.
The decision to join is yours. We are happy to answer any questions you may have before and after signing up. Please contact us at OneDukeGen@duke.edu or by phone at 919-257-0752.
If you decide to join, we will collect either a blood or saliva sample. Your Duke My Health portal message will tell you which sample we need.
- An appointment to collect a blood sample (about 2.5 tablespoons) will be added to a already scheduled appointment at a Duke Health clinic or hospital, so you don’t need to make a special trip.
- A kit to collect a saliva (spit) sample (less than half a teaspoon) will be mailed to you with instructions and a prepaid envelope for easy return.
No matter which way you participate, it won’t cost you anything. You will also not receive compensation for participating or for any new discoveries that used your data.
OneDukeGen will store your samples for researchers to use in studies to learn more about genetic changes linked to health. Genes are only one of many factors that can impact health, so researchers will also analyze information about people’s behaviors and lifestyles along with genetic information. You can think of it as a puzzle, where researchers are trying to find the pieces that go together for a specific health condition. As researchers gather more puzzle pieces, they can gain a clearer picture of how our bodies work and why they sometimes don't work the way we expect.
Do I receive my genetic test results back?
If you join the study, you have the option of deciding if you would like to learn of genetic health information that increases your risk of a treatable health condition. We expect to find these results in about 5% (1 out of 20) of people. So, most people will not have a genetic change that increases their risk for disease. If you choose to receive results from the study, we will tell you about your genetic risk of health conditions that are potentially treatable or preventable, as defined by the American College of Medical Genetics. If we don’t find any health-related changes in your DNA, we will not contact you.
You can still participate in the study even if you do not want results returned to you.
The OneDukeGen team follows accepted community standards on returning genetic results. A group of Duke medical providers, scientists, and community advocates at Duke agree on what is considered for return, which may change as the medical community learn more.
Here are some of the conditions you may receive a result on:
Hereditary Cancer Conditions
These conditions are associated with an increased chance of cancer. Management for these conditions may include specific screening tests or surgeries.
- Breast cancer – Individuals with these conditions have an increased chance of having breast and some other types of cancer, which may affect biological men and biological women Management may include tests such as mammograms, MRIs, or surgery.
- Colon cancer - Individuals with these conditions have an increased chance of having colon and some other types of cancer. Management may include tests such as colonoscopies, surgery, or other more specialized procedures.
- Other cancers – Individuals with these conditions have an increased chance of developing certain rare cancers. Management may include tests such ultrasounds, surgery, or other more specialized procedures.
Cardiovascular Disease
These conditions impact the function of the heart, including issues with the heart muscle, rhythm or vessels. Individuals with these conditions may follow up with specialized cardiologists, have increased heart screening (such as EKGs or echocardiograms), or take preventative medications.
- Cardiomyopathies – Conditions that impair the heart muscle's normal function. Arrhythmias –Conditions that affect the heart’s rhythm or beat, causing the electricity in the heart to not work as expected.
- Vascular – Conditions that affect the body’s blood vessels.
- Hereditary high cholesterol – A genetic form of high cholesterol.
Other Conditions
Conditions in this category relate to the function of varying body systems, including the eyes and muscles.
What should I expect if I have a result returned to me?
If we find a result for a preventable health condition and you have told us you’d like to receive them, we will first reach out to you to confirm that you would still like this information and haven’t changed your mind. If so, You will next meet with a genetic counselor on the study team. They will review the genetic change discovered; explain how it may affect your health, your family, and their health and what steps to take next. The genetic counselor will answer any questions you may have. This service will be provided for free.
We will provide you with a summary report of the result. It will include all of the information that was discussed with you, including an explanation of the genetic change, the health condition you are at-risk for, how the condition may be treated, and how to receive care for this condition at Duke.
We will also give you a medical guide based on your specific genetic change(s) and condition. These may include preventative care and treatment options to reduce your risk or to detect it early.
Preventative care may include:
- Annual screening for heart disease or cancer, including blood tests, imaging (MRI, EKG, ultrasound, etc.), and physical examinations
- Medications to prevent symptoms from developing, for example blood pressure medications
- Preventative surgeries, for example removing breast tissue (mastectomy) to lower breast cancer risk in women found to have an elevated risk, or implanting a cardiac device before ever having a heart attack.
We will help guide you to find the appropriate follow-up care at a Duke clinic.
This study will give results for a pre-determined list of diseases that are well known to be treatable or preventable. Other genetic results will not be returned.Since this is a research study and we might not be returning genetic information related to the medical conditions you have, these results cannot replace your regular medical care.
Genetic conditions can be inherited or passed on in several ways. Sometimes one gene passed down from a parent is enough to cause disease.
We may make recommendations for family members depending on the genetic change found. Usually, genetic testing is used to determine if family members have the same genetic change.
We cannot provide an exact time frame to get results. Since this is a research test, if you have results to be returned, it could take years to receive results.
This is a summary of what will happen in the OneDukeGen study. For more details and important information, please follow the consent document link in your Duke My Health message. You can decide to join the study after you review the consent document.