Clinical trial NCT05045222: Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
Official title: ECOST = Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Health Care Utilization
Keywords: Tapestry
Quality of life - adjusted life years
ECOST
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life measured through adjusted years.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Disease incidence measured by disease count per 100 participants.
timeFrame: 12 months
measure: Change in utilization measured by total number of office visits, hospital stays, ER visits, and length of visits.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Change in costs measured by disease related and all-cost related costs.
timeFrame: Every 12 months for 5 years after enrollment.
Secondary outcomes:
measure: Change in quality of life measured through adjusted years from subgroups.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Change in quality of life measured through adjusted years from different scenarios.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Disease incidence from subgroups.
timeFrame: 12 months
measure: Disease incidence from different scenarios..
timeFrame: 12 months
measure: Change in utilization from subgroups.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Change in utilization from different scenarios.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Change in costs from subgroups.
timeFrame: Every 12 months for 5 years after enrollment.
measure: Change in costs from different scenarios.
timeFrame: Every 12 months for 5 years after enrollment.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Niloy Jewel Samadder, MD
role: PRINCIPAL_INVESTIGATOR
References: