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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05045222
Other study ID # 20-010400
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 29, 2021
Est. completion date July 31, 2032

Study information

Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100000
Est. completion date July 31, 2032
Est. primary completion date July 31, 2031
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in quality of life measured through adjusted years. Measuring quality of life through adjusted years due to learning Tapestry test results. Every 12 months for 5 years after enrollment.
Primary Disease incidence measured by disease count per 100 participants. Number of disease incidences per 100 participants. 12 months
Primary 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. Every 12 months for 5 years after enrollment.
Primary 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. Every 12 months for 5 years after enrollment.
Secondary 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. Every 12 months for 5 years after enrollment.
Secondary 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. Every 12 months for 5 years after enrollment.
Secondary Disease incidence from subgroups. Number of disease incidences per 100 hundred participants categorized by subgroups: minority races, 65 years and older, etc. 12 months
Secondary 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. 12 months
Secondary 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. Every 12 months for 5 years after enrollment.
Secondary 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. Every 12 months for 5 years after enrollment.
Secondary 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. Every 12 months for 5 years after enrollment.
Secondary 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. Every 12 months for 5 years after enrollment.
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