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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Health Care Utilization

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life measured through adjusted years from subgroups.	Measuring quality of life through adjusted years due to learning Tapestry test results categorized by subgroups: minority races, 65 years and older, etc.	Every 12 months for 5 years after enrollment.
Change in quality of life measured through adjusted years from different scenarios.	Measuring quality of life through adjusted years due to learning Tapestry test results categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc.	Every 12 months for 5 years after enrollment.
Disease incidence from subgroups.	Number of disease incidences per 100 hundred participants categorized by subgroups: minority races, 65 years and older, etc.	12 months
Disease incidence from different scenarios..	Number of disease incidences per 100 hundred participants categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc.	12 months
Change in utilization from subgroups.	Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits. All categorized by subgroups: minority races, 65 years and older, etc.	Every 12 months for 5 years after enrollment.
Change in utilization from different scenarios.	Composite of: Number of Office-based visits. Number of Hospital stays and length of visits. Number of ER visits. All categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc.	Every 12 months for 5 years after enrollment.
Change in costs from subgroups.	All-cause costs. All-cause costs by utilization category. All categorized by subgroups: minority races, 65 years and older, etc.	Every 12 months for 5 years after enrollment.
Change in costs from different scenarios.	All-cause costs. All-cause costs by utilization category. All categorized by different scenarios: disease comorbidities, patient income, education, adherence to medical orders, etc.	Every 12 months for 5 years after enrollment.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Niloy Jewel Samadder, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2031

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tapestry; Quality of life - adjusted life years; ECOST
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care
• Other Study ID Numbers: 20-010400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No