Health Care UtilizationECOSTNCT05045222
Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
An observational study of Health Care Utilization, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- How many people
- 100,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2021to 31 Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: 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.
- Conditions
- Health Care Utilization
- Keywords
- Tapestry, Quality of life - adjusted life years, ECOST
- Medical subject headings
- Patient Acceptance of Health Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life measured through adjusted years.
Measuring quality of life through adjusted years due to learning Tapestry test results.
Measured: Every 12 months for 5 years after enrollment.
Disease incidence measured by disease count per 100 participants.
Number of disease incidences per 100 participants.
Measured: 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.
Measured: 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.
Measured: Every 12 months for 5 years after enrollment.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every 12 months for 5 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start29 Oct 2021
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niloy Jewel Samadder, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045222
- Sponsor's protocol ID
- 20-010400
- Acronym
- ECOST
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECOST = Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
- ClinicalTrials.gov ID
- NCT05045222
- Acronym / sponsor ID
- ECOST / 20-010400
- Conditions
- Health Care Utilization
- Keywords
- Tapestry, Quality of life - adjusted life years, ECOST
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Disease incidence measured by disease count per 100 participants.
Time frame: 12 months
Number of disease incidences per 100 participants.
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.
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.
8 secondary outcomes
Change in quality of life measured through adjusted years from subgroups.
Time frame: 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.
Disease incidence from subgroups.
Time frame: 12 months
Disease incidence from different scenarios..
Time frame: 12 months
Change in utilization from subgroups.
Time frame: Every 12 months for 5 years after enrollment.
Change in utilization from different scenarios.
Time frame: Every 12 months for 5 years after enrollment.
Change in costs from subgroups.
Time frame: Every 12 months for 5 years after enrollment.
Change in costs from different scenarios.
Time frame: Every 12 months for 5 years after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niloy Jewel Samadder, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Utilization, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life measured through adjusted years. (time frame: Every 12 months for 5 years after enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.