Mayo Clinic Health TAPESTRY: Use of Genomic Sequencing in Clinical Practice

Overview

About this study

Tapestry is a Mayo Clinic research study, which includes receiving genetic sequencing data from Helix, up to the full whole exome dataset. The goal of this study is to provide: (i) an immediate interpretation of ancestry/genealogy and several non-disease traits, as well as, clinically actionable variants for an inherited form of high cholesterol called familial hypercholesterolemia (FH), breast and ovarian cancer (HBOC), and Lynch syndrome to each participant; (ii) an additional subset of focused clinically actionable genetic findings, such as, certain types of hereditary cancers, hereditary heart conditions and severe responses to certain medications, will be returned to the provider and to the participant, via the provider, genetic counselor consultation, and/or Mayo Clinic research interpretation; (iii) storing of genomic and phenotypic data for future research analysis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Registered Mayo Clinic patient.
  • Able to provide informed written consent.
  • E-mail and web access (for electronic consent, video education, registering with Helix and receiving results).
  • Ability to collect and ship saliva sample within the United States.

Exclusion Criteria:

  • Other co-morbidity which would in physician’s opinion interferes with patient’s ability to participate in the study (e.g., reduced ability to comprehend; e.g., dementia, intellectual disability, fluency in consent language).
  • Allogeneic Bone Marrow Transplant (e.g., samples from autologous bone marrow transplant recipients are acceptable if collected at least one month after transplant).
  • Active hematological cancer.
  • Resident of the state of New York.
    • The Helix lab does not currently have New York state licensure.
  • Residents without a shipping address in the United States.
    • The Helix lab is unable to ship and receive samples internationally.

Of note: Women, who are pregnant, or planning to become pregnant, can take part in this study. However, this study does not replace prenatal genetic testing. If participants have these concerns, they will be encouraged to contact their obstetrics (OB) provider or a genetic counselor to discuss further.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sanjay Bagaria, M.D.

Open for enrollment

Contact information:

CIM CRC Study Team Contact

Tapestry@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Lazaridis, M.D.

Open for enrollment

Contact information:

CIM CRC Study Team Contact

Tapestry@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aleksandar Sekulic, M.D., Ph.D.

Open for enrollment

Contact information:

CIM CRC Study Team Contact

Tapestry@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20477323

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