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Enrolling by Invitation

NCT Number: NCT05045222

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.

Enrolling by Invitation

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Key information

Conditions

Health Care Utilization Behavior Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Disease incidence measured by disease count per 100 participants.

    Time frame: 12 months

    Number of disease incidences per 100 participants.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: ECOST

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Sep 16, 2021
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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