Participation

What will I learn?

If you enroll in the Tapestry DNA Sequencing Research Study, you will learn about some genetic risk factors that could impact your medical care.

Future research

Mayo Clinic is collaborating with the genomics company Helix to collect and sequence human DNA. Your genetic data will be stored at both Mayo Clinic and Helix.

At Mayo Clinic, your genetic information will be stored in the Tapestry study's library, also called a registry. Information in this library — including your genetic information — may be used for future research or commercial use by researchers at Mayo Clinic, Helix or other organizations. Your information is shared with Helix for the Tapestry study, but not for future research. Mayo Clinic will not share any of your personal information with anyone outside of Mayo.

There is a small chance that future research could find information relevant to your health care. If this happens, you would be contacted by Tapestry and would need to decide whether you want to learn this information. Because the Tapestry study team can't predict future research areas or results, the results could be surprising to you.

Can I join the study?

You may be able to be part of the Tapestry study if you:

• Are 18 years old or older.
• Are a registered Mayo Clinic patient.
• Are able to provide informed written consent.
• Have email and internet access.
  • Email and internet access are necessary to complete the electronic consent document, receive video education, register with Helix and receive results.
• Are able to collect and ship a spit (saliva) sample within the United States.

You are not allowed to participate in the Tapestry study if you:

• Are a patient with an active blood cancer, also called hematologic cancer, or a history of blood cancer.
• Are a recipient of a bone marrow transplant in which someone else donated the bone marrow, also called an allogeneic transplant.
• Are a resident of the state of New York.
  • The Helix laboratory does not currently have a license in New York state.
• Do not have a shipping address in the United States.
  • The Helix laboratory cannot ship and receive samples outside the United States.

What to expect

If you join Tapestry:

• The Tapestry study team will send you a spit collection kit in the mail. This is also called a saliva collection kit.
• You will create a Helix account and register your saliva kit online.
• You will collect your saliva sample and send it to the Helix laboratory in the provided box.
• Helix will sequence your DNA to learn about your unique genes.
• The Tapestry study team will send you a survey about your participation.
• The Tapestry study team will send you a link to Mayo Clinic's About Me family history tool, and you will build your family tree through this application.
• You will get results from Helix telling you if you are at risk of familial hypercholesterolemia (FH), hereditary breast and ovarian cancer (HBOC) syndrome, or Lynch syndrome. To learn more about these conditions, you can:
  • Visit Mayo Clinic's webpage about FH
  • Download a PDF from Mayo Clinic about hereditary breast and ovarian cancers
  • Visit Mayo Clinic's webpage about Lynch syndrome
• You can choose to get results from Helix about your family background and qualities that could have been passed down through your genes. Family background is also called ancestry. Qualities passed down through genes are also known as genetic traits.
• You might get more results in the future. This could include your risks of other types of cancers, heart conditions and other health conditions because of your genes.
• Your genetic information will be placed in a library, also called a registry, of genetic information for future research.
• If your results show that you have a change in your genes that could impact your health, the Tapestry study team will contact you to schedule a time for you to speak with a genetic counselor. This visit will be paid for by the study.

Results

After the Tapestry study team completes your genetic analysis, you will receive the following results. If you want to learn the optional results about your family background and qualities that could have been passed down through your genes, you will need to sign a form to allow Helix to use your genetic data to provide these results.

Study feature	Purpose	Entered into your electronic health record (EHR)?	Provided by
Hereditary breast and ovarian cancer (HBOC) syndrome screening	You'll learn if you're at risk of developing breast, ovarian or other cancers, such as prostate cancer, due to risk factors in your genes. This study will not diagnose cancer.	Yes	Helix Health
Lynch syndrome screening	You'll learn if you're at risk of developing colon, endometrial or several other cancers due to risk factors in your genes. This study will not diagnose cancer.	Yes	Helix Health
Familial hypercholesterolemia (FH) screening	You'll learn if you're at risk of developing an inherited form of high cholesterol that significantly increases your risk of heart attack at a young age.	Yes	Helix Health
Tapestry research	Your genetic information from this study will be stored in a registry and possibly used in future studies. This means additional genes may be screened for research-only reasons.	If additional screening finds a gene that may impact your health, the Tapestry team will contact you. You can decide if you want to learn more about the result. If you choose to learn more, a note with the result will be entered into your EHR. If you choose not to learn more, nothing will be entered into your EHR.	Tapestry
Family background (ancestry) — optional	You will learn about your ancestry and how your ancient relatives' DNA may affect you.	No	Helix Ancestry
Inherited qualities (genetic traits) — optional	Your results will highlight how DNA influences your traits — from caffeine metabolism to type of ear wax.	No	Helix Traits

Your results may become part of your electronic health record. If you do not want the results of this genetic testing to be part of your electronic health record, you should not take part in this study.

Please visit the Tapestry study's Resources page and Frequently Asked Questions page to learn more before deciding to take part in this research study.

Costs

The Mayo Clinic Center for Individualized Medicine and Helix provide the following parts of the Tapestry study at no cost to you:

• An educational video about genetic testing to watch before taking the test
• Spit (saliva) collection kit and shipping
• DNA sequencing
• Familial hypercholesterolemia (FH) screening test
• Hereditary breast and ovarian cancer (HBOC) syndrome screening test
• Lynch syndrome screening test
• An online Helix account, which includes the option to receive ancestry and traits results
• A phone call with a genetic counselor to discuss any results that may impact your health
• Additional research testing

You or your insurance provider will need to pay for all other tests and procedures that are part of your care outside of the study, including copayments and deductibles.

The Tapestry study team generally recommends more testing for less than 1% of participants. This testing needs to be done outside of Helix to confirm whether the first results were correct. You, your insurance provider or both would need to pay for the extra tests. If the Tapestry test results show that you need additional medical care, you or your insurance provider would need to pay for that too.

Risks

Before you agree to join the Tapestry study, you need to be aware of the following risks:

• Confidentiality risk. As with all research, there is a chance that your medical information could be revealed to people who shouldn't see it. However, the Tapestry research team takes precautions to decrease this risk.
• Genetic testing. The risks of learning genetic test results may include upsetting or negative emotions as well as discrimination by life insurance, long-term care insurance or disability insurance companies.

Genetic Information Nondiscrimination Act (GINA)

A federal law called the Genetic Information Nondiscrimination Act (GINA) makes it illegal for health insurance companies, group health plans and most employers to discriminate against you based on your genetic information. More information can be found on the GINA website or at the Tapestry study's Resources page.

Register now

If you are interested in joining the Tapestry study, please submit the form linked below. If you are eligible, the study team will send you a consent document with more details. If you choose to electronically sign the consent document and return it to the study team, you are giving your consent to be part of the Tapestry study.

Complete the eligibility form.