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

April 15, 2026 updated by: Mayo Clinic

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in quality of life measured through adjusted years.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: 12 months
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.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: Every 12 months for 5 years after enrollment.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life measured through adjusted years from subgroups.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: 12 months
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..
Time Frame: 12 months
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.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: Every 12 months for 5 years after enrollment.
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.
Time Frame: Every 12 months for 5 years after enrollment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niloy Jewel Samadder, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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