Participation

What will I learn?

Participants in the Tapestry DNA Sequencing Research Study will learn about some genetic risk factors that may impact their medical care.

Future research

Your data will be stored in the Tapestry genomic registry for future research or commercial use. Results related to other health conditions may be returned to you as a result of future research. You may find these results unexpected because future use of your data cannot be predicted at this time.

Can I participate?

You may be able to participate in the Tapestry study if you are:

  • 18 years old or older
  • A registered Mayo Clinic patient

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

  • A resident of the state of New York
  • A patient with an active blood (hematologic) cancer
  • A recipient of a bone marrow transplant

What to expect

If you join Tapestry:

  • You will receive a spit (saliva) kit.
  • You will create a Helix account and register your saliva kit online.
  • You will collect your saliva sample and send it back in the provided box.
  • Helix will perform DNA sequencing.
  • You will receive a survey about your participation.
  • You will receive a link to Mayo Clinic's About Me family history tool and will build your family tree through this application.
  • You will receive results for familial hypercholesterolemia (FH), hereditary breast and ovarian cancer (PDF), and Lynch syndrome from Helix.
  • You may receive ancestry and trait information from Helix.
  • You may receive additional results in the future. This could include your risks of other types of hereditary cancers, hereditary heart conditions and other health conditions.
  • Your genetic information will be placed in a library of genetic information (registry) for future research.
  • If your results show that you have a genetic variant that may 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 results related to:

Features of Tapestry Study

Helix Health

Features

Helix Health

  • Hereditary breast and ovarian cancer
  • Lynch syndrome (colon, endometrial and several other cancers)
  • Familial hypercholesterolemia (FH)

Your Genetic Results/Data

You will learn if you are at higher risk:

  • To develop certain cancers due to inherited (hereditary)risk factors. This study will not diagnose cancer.
  • Of an inherited form of high cholesterol (FH) that significantly increases a person's risk of heart attack at a young age.

Entered into the Electronic Health Record (EHR)

Yes

Tapestry

Features

Tapestry

  • Research
  • Genomic Registry

Your Genetic Results/Data

You will learn if you are at higher risk:

  • Additional genes will be accessed as part of this study.
  • Your genetic data from this study will be stored in a registry and possibly used in future studies.

Entered into the Electronic Health Record (EHR)

Results that impact your health may be entered into your EHR

You also have the option to receive ancestry and nonmedical genetic traits results from Helix. If interested, you will need to sign an authorization to allow Helix to use your genetic data to provide these results.

Optional Features

Features

Helix Ancestry

Your Genetic Results/Data

  • You will learn about your ancestry and how your ancient relatives' DNA may affect you.

Entered into the Electronic Health Record (EHR)

No

Features

Helix Traits

Your Genetic Results/Data

Your results will highlight how DNA influences your traits — from caffeine metabolism to type of ear wax.

Entered into the Electronic Health Record (EHR)

No

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.

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

In the future, Mayo Clinic, Helix or other researchers may request to access the data for research purposes or commercial use. No personal information, such as your name or other identifying details, will be shared with external parties.

Please visit the Tapestry study's Resources 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 as part of the Tapestry study at no cost to you:

  • Pretest genetic counseling
  • Spit (saliva) collection kit and shipping
  • DNA sequencing
  • Familial hypercholesterolemia (FH) screening test
  • Hereditary breast and ovarian cancer screening test
  • Lynch syndrome screening test
  • Helix account, which includes the option to receive ancestry and traits results
  • Return of results that may impact your health (phone call with genetic counselor)
  • Additional research testing

However, you or your insurance will need to pay for all other tests and procedures that you would have as part of your clinical care, including copayments and deductibles. This includes any confirmatory testing related to this study that may be recommended.

Risks

Giving informed consent to participate in the Tapestry study includes being aware of the following risks:

  • Confidentiality risk. As with all research, there is a chance that the confidentiality of your medical information could be compromised; however, the Tapestry research team takes precautions to decrease this risk.
  • Genetic testing. The risks of learning genetic test results may include emotional upset or insurance or job discrimination.

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 participating in the Tapestry study, please submit the eligibility form. If you are eligible, you will receive a consent document by email. More details about the Tapestry study are outlined in this document. If you choose to electronically sign and submit the consent document, you are agreeing to participate in the Tapestry study.