Enrolling by invitation NCT05045222

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

— Observational Health Care Utilization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Health Care Utilization. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Change in quality of life measured through adjusted years. [Time frame: Every 12 months for 5 years after enrollment.]
Disease incidence measured by disease count per 100 participants. [Time frame: 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.]
Change in costs measured by disease related and all-cost related costs. [Time frame: Every 12 months for 5 years after enrollment.]

Secondary outcome measures (8)

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.]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

United States · 2 centers

NCT: NCT05045222 · 20-010400