[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05045222":3,"trial-entities:NCT05045222":114,"trial-summary:NCT05045222":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":45,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":84,"locations":87,"central_contacts":104,"overall_officials":105,"references":109,"see_also_links":110},"NCT05045222","20-010400","Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry","ECOST = Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry","ENROLLING_BY_INVITATION","2031-07-31","2026-04","2026-04-20","2021-10-29","Mayo Clinic","OTHER",false,"The purpose of this research is to learn more about the impact of genetic testing on healthcare costs, clinical care, and quality of life.",null,[19],"Health Care Utilization",[21,22,23],"Tapestry","Quality of life - adjusted life years","ECOST","OBSERVATIONAL",[],{"count":27,"type":28},100000,"ESTIMATED",[],[31,35,39,42],{"measure":32,"description":33,"timeFrame":34},"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.",{"measure":36,"description":37,"timeFrame":38},"Disease incidence measured by disease count per 100 participants.","Number of disease incidences per 100 participants.","12 months",{"measure":40,"description":41,"timeFrame":34},"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.",{"measure":43,"description":44,"timeFrame":34},"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.",[46,49,52,55,58,61,64,67],{"measure":47,"description":48,"timeFrame":34},"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.",{"measure":50,"description":51,"timeFrame":34},"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.",{"measure":53,"description":54,"timeFrame":38},"Disease incidence from subgroups.","Number of disease incidences per 100 hundred participants categorized by subgroups: minority races, 65 years and older, etc.",{"measure":56,"description":57,"timeFrame":38},"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.",{"measure":59,"description":60,"timeFrame":34},"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.",{"measure":62,"description":63,"timeFrame":34},"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.",{"measure":65,"description":66,"timeFrame":34},"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.",{"measure":68,"description":69,"timeFrame":34},"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.","ALL","18 Years",true,{"inclusion":74,"exclusion":78,"raw_text":83},[75,76,77],"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.",[79,80,81,82],"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.","Inclusion Criteria:\n\n* Tapestry patients who have received genetic results, regardless of positive or negative testing results.\n* Age of 18 and older.\n* Patients with an established Mayo Clinic provider prior to their enrollment in Tapestry.\n\nExclusion Criteria:\n\n* Individuals less than 18 years old.\n* Patients without capacity to consent (i.e., needing legal authorized representatives).\n* Prisoners.\n* Subjects eligible for chart review, without a Minnesota Research Authorization on record.",[85,86],"ADULT","OLDER_ADULT",[88,97],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"Mayo Clinic in Arizona","Scottsdale","Arizona","85259","United States",{"lat":95,"lon":96},33.50921,-111.89903,{"facility":13,"city":98,"state":99,"zip":100,"country":93,"geoPoint":101},"Rochester","Minnesota","55905",{"lat":102,"lon":103},44.02163,-92.4699,[],[106],{"name":107,"affiliation":13,"role":108},"Niloy Jewel Samadder, MD","PRINCIPAL_INVESTIGATOR",[],[111],{"label":112,"url":113},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Genetic Disorder",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]