Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry

NCT05045222 | Enrolling By Invitation

• 1 other identifier: 20-010400
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to learn more about the impact of genetic testing on healthcare costs, clinical care, and quality of life.

Conditions

Health Care Utilization

Keywords

Tapestry; Quality of life - adjusted life years; ECOST

Outcome Measures

Primary Outcomes (4)

• Change in quality of life measured through adjusted years.

  Measuring quality of life through adjusted years due to learning Tapestry test results.

  Every 12 months for 5 years after enrollment.

• Disease incidence measured by disease count per 100 participants.

  Number of disease incidences per 100 participants.

  12 months

• Change in utilization measured by total number of office visits, hospital stays, ER visits, and length of visits.

  Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits.

  Every 12 months for 5 years after enrollment.

• Change in costs measured by disease related and all-cost related costs.

  Cost Composite of: Disease-related costs. Disease-related costs by utilization category. All-cause costs. All-cause costs by utilization category.

  Every 12 months for 5 years after enrollment.

Secondary Outcomes (8)

• Change in quality of life measured through adjusted years from subgroups.

  Every 12 months for 5 years after enrollment.

• Change in quality of life measured through adjusted years from different scenarios.

  Every 12 months for 5 years after enrollment.

• Disease incidence from subgroups.

  12 months

• Disease incidence from different scenarios..

  12 months

• Change in utilization from subgroups.

  Every 12 months for 5 years after enrollment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants of the Tapestry study, which is an ongoing project aimed at studying the genetic risk factors that impact medical care of patients at Mayo Clinic. This study will include the first 15,000 Tapestry patients who received results of 11 genes (incidental findings) after undergoing WES using a saliva sample and were enrolled January 2020 onwards. Chart review of up to 85,000 records will accompany the 15,000 enrolled and completing surveys for a total of 100,000 accrued.

You may qualify if:

• Tapestry patients who have received genetic results, regardless of positive or negative testing results.
• Age of 18 and older.
• Patients with an established Mayo Clinic provider prior to their enrollment in Tapestry.

You may not qualify if:

• Individuals less than 18 years old.
• Patients without capacity to consent (i.e., needing legal authorized representatives).
• Prisoners.
• Subjects eligible for chart review, without a Minnesota Research Authorization on record.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Niloy Jewel Samadder, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 16, 2021
• Study Start: October 29, 2021
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2031
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (2)