On July 11th, 2019, Gilead Sciences, Inc. and the Renown Institute for Health Innovation (IHI) announced a strategic collaboration to collect and analyze de-identified genetic and electronic health data that can enhance the understanding of a type of liver disease called Nonalcoholic Steatohepatitis (NASH) and potentially inform development of treatment options for the disease.
Renown IHI has begun enrollment for the Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study and is currently available online to Renown patients who have not already participated in the Healthy Nevada Project.
This is an observational study trying to understand genetic links to Nonalcoholic Steatohepatitis or NASH and is being performed in conjunction with the Healthy Nevada Project.
De-identified genetic information from the Healthy Nevada Project and de-identified information from a patient’s medical record, such as blood tests or imaging tests, will be used to study NASH. Some participants may be asked to provide a blood sample or undergo imaging tests so that information can be used for research. All of the information collected for the study will be stored in a database as de-identified information to ensure patient privacy and adhere to the study’s strict data policies.
How The Process Works
Review and Sign the Consent Form
If you are a Renown patient and not already enrolled in the Healthy Nevada Project, you can click the Join Now button below to read and electronically sign our consent form to be in these studies from home. If you have any questions about these studies, please email us at RenownIHI@renown.org and our research staff will contact you.
After you have completed our consent form, you will be shipped a saliva kit in 1-2 weeks to your mailing address from our sequencing partner, Helix. Following instructions from the kit, you will create a Helix account, register your kit, and provide a small saliva sample. Afterwards, just send the sample back to Helix in the prepaid return box.
Review Your Results
Within 4-8 weeks, you will receive an email letting you know when your results are ready, and you can access them through your account on the Helix website. If a hereditary risk is detected or if we would like you do additional tests for the NASH trial, you will be contacted directly by our research team.
What Participants Receive
My Healthy Nevada Traits
Learn and explore genetic insights related to your own ancestry and how your DNA can influence your body’s response to the foods you eat. Our exclusive My Healthy Nevada Traits application on the Helix website provides everyone who participants with genetic insights based off of their DNA that include: Regional Ancestry, Lactose Tolerance, Gluten Tolerance, BMI Introduction, Vitamin D Levels, Coffee Consumption, Saturated Fat and Calcium Levels.
The Healthy Nevada Project currently provides genetic reports to participants who opt-in to learn if they have gene variants that can cause an increased risk to develop one or more of the following conditions: Familial Hypercholesterolemia (FH), Hereditary Breast and Ovarian Cancer Syndrome (HBOC) and Lynch Syndrome. You will only be contacted regarding clinical results if a gene variant is detected in the screening and you consent to be contacted regarding those results.
Frequently Asked Questions
Q: What is NAFLD and NASH?
A: Nonalcoholic Fatty Liver Disease (NAFLD) is a build-up of fat in the liver of people who don't abuse alcohol. It is normal for the liver to contain some fat, but if more than 5 percent of the liver’s weight is fat, it’s considered a fatty liver (steatosis). NASH stands for Nonalcoholic Steatohepatitis and is the most severe form of NAFLD in which you have liver cell damage and hepatitis (inflammation) of the liver. Inflammation and liver cell damage can cause fibrosis, or scarring of the liver, and can cause decreased liver function (2). The symptoms for NASH are often silent or non-specific, making it difficult to diagnose. About one-third of people with NASH develop cirrhosis or irreversible liver damage (1).
Q: How does someone get NASH?
A: There are a number of genes that contribute to Nonalcoholic Steatohepatitis (NASH). If a person has family members who had or currently have NASH or Nonalcoholic Fatty Liver Disease (NAFLD), they may be at risk. Additionally, having certain health conditions may increase a person’s risk to develop NASH. These include: being overweight or obese, having high cholesterol or high triglyceride levels, having type 2 diabetes, and having insulin resistance or prediabetes (3).
Q: How common is NAFLD and NASH
A: Nonalcoholic Fatty Liver Disease (NAFLD) is the most common chronic liver condition in the United States. Although the condition is thought to be under- diagnosed and estimates very, it is predicted that 1 out of 4 adults in the U.S have NAFLD. Of those with NAFLD, about 20 percent have Nonalcoholic Steatohepatitis (NASH) (2). That equates to approximately 2-5% of adults in the U.S. or 6.5 – 16.3 million people who may have NASH (2).
Q: Why is this study looking at NASH?
A: This study aims to understand the relationship between genes and the liver disease Nonalcoholic Steatohepatitis, or NASH, for which there is no current FDA approved therapy. Specifically, we want to understand whether specific germline mutations in genes are more prevalent in people with NASH. We also want to understand whether specific germline mutations in genes are more prevalent in people who are possibly resistant to NASH.
We hypothesize that certain germline mutations are more prevalent in NASH cases, and perhaps this knowledge can be used in developing better therapies or in risk mitigation of the disease. In other words, we believe that participants with specific mutations (differences) in liver-related-genes may have increased risk for disease. We want to test this hypothesis. For this study, we want to understand the relationships between germline mutations and NASH.
Q: How is NASH diagnosed?
A: Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) can be difficult to diagnose because most people who have it show no symptoms until the disease is well advanced. This can be dangerous because NASH can lead to serious liver damage. NASH is usually first suspected when a healthcare provider finds abnormal results from routine blood or liver tests that may be part of a physical examination, or imaging tests show fat in the liver (2).
You should speak to your doctor if you feel that you may be at risk for NAFLD or NASH and continue to see your physician for routine care.
Q: Are there treatments for NAFLD and NASH?
A: There are currently no approved medications for the treatment of Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH). Therefore, additional research is needed to develop new treatments. Most frequently, medical professionals recommend weight loss as the first step in treating the diseases. Losing weight can help reduce fat, scarring, and inflammation in the liver. Maintaining a healthy lifestyle by limiting fats and sugars in a person’s diet and avoiding heavy alcohol can help avoid further damage to the liver (2).
Q: Why have I been asked to participate in the Nonalcoholic Steatohepatitis (NASH) study?
A: We are asking participants to consider being a part of this study to help us learn why some people develop a type of liver disease called Nonalcoholic Steatohepatitis (NASH) and why some people do not. There are currently no accepted FDA approved drugs to treat NASH, and we need volunteers at various risk for the disease to develop new treatments. By analyzing genetic information from participation in the Healthy Nevada Project and medical record information, we hope to be able to develop new therapies and treatments for the disease.
Q: What can I expect if I participate in the Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study?
A: If you have not participated in the Healthy Nevada Project, you will be asked to join as an inclusion criteria for participation in this study. The Healthy Nevada Project is a clinical research study that provides de-identified genetic data that can be used for research using a small saliva sample. You will be asked to go through the consent process for the Healthy Nevada Project if you are not already enrolled in the project.
As a participant in this study, you will be asked to allow us access to your medical information to be used in a de-identified data set for research and development, and associate that information with your de-identified genetic information in our joint genetic and health information database. You may be periodically contacted via email with important information, such as new research developments, surveys, insights or opportunities being offered to participants.
It is possible that you may be asked to provide a blood sample which will be used in an enhanced liver fibrosis (ELF) test or similar diagnostic test, or asked to have an imaging test performed, such as elastography or liver elastography, that checks the liver for fibrosis. Not all participants will be asked to undergo these tests, and if you are asked, they can be conducted at your convenience.
Q: Is there any cost associated with being in this study?
A: Participation in this research study is offered at no cost. Participants receive no-cost genetic sequencing, ancestry, and wellness insights through the Healthy Nevada Project. As a participant in the Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study, any tests requested as a component of the research study, such as blood or imaging tests, will also be provided at no cost.
If you are asked to provide a blood sample or have imaging performed, you will be provided with clinical diagnostic information from these tests. The results of the tests will be put in your medical record and will be available to your doctor to help direct your care. Visits to your doctor, whether directly or indirectly related to this study, are not covered.
Healthy Nevada Project’s Milestones
Learn more about the study’s progress and positive impact on residents of Nevada below.
Knowledge Is Power
Betsey Brownfield’s Healthy Nevada Project, Helix genetic test, showed she carries the BRCA1 mutation. She began taking action to prevent the odds of getting cancer. She had an MRI, which was negative for breast cancer. She is continuing to monitor her breast health and is deciding whether or not to have a double mastectomy.
Jordan Stiteler’s dad died suddenly of a stroke nearly ten years ago — at only 45 years old. Her grandfather died at age 40. Now through the Healthy Nevada Project’s no-cost genetic testing, she is closer to understanding why that may have happened. And she can take proactive steps to prevent the unhealthy symptoms that often lead to a stroke.
Lives impacted through actionable results to date.
Received actionable medical results across 3 conditions.
Would have been missed under
current medical practice.