Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment

NCT03803293 | Completed

• 1 other identifier: 12-003371
• Study Type: interventional
• Target: 11,098
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being done to better understand how genetic information related to drug dosing and use can affect medical care of patients. By doing this study, the investigators are developing and improving ways to incorporate information about drug related genetic variants into the medical record.

Conditions

Healthy Subjects

Keywords

Pharmacogenomics; Personalized Medicine; Pharmacogenomic Varients

Outcome Measures

Primary Outcomes (1)

• Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug

  Total number of subjects identified with high risk for being prescribed a PGx drug

  Baseline

Study Arms (1)

Primary cohort

OTHER

All eligible Biobank participants that receive the majority of their care at Mayo Clinic based on EHR length and depth had pharmacogenomic testing done.

Diagnostic Test: Pharmacogenomic testing

Interventions

Pharmacogenomic testing DIAGNOSTIC_TEST

A comprehensive PGx interpretive report created by OneOme (www.oneome.com) provides information on how an individual patient's genes may affect medication response. OneOme utilizes algorithms and curated clinical PGx knowledge to generate a highly intuitive personalized report based on a patient's genomic results.

Primary cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biobank participants who receive the majority of their care at Mayo Clinic based on EHR length and depth.

You may not qualify if:

• Not in the Mayo Clinic Biobank. Do not receive the majority of their care at a Mayo Clinic site.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Suzette Bielinski, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The Mayo Clinic Biobank is an institutional resource comprised of adult community volunteers who donated biological specimens, provided risk factor data, access to EHR data, and consented to participate in additional studies. Subjects in the Mayo Clinic Biobank are the cohort that was recruited to participate in the RIGHT study.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 14, 2019
• Study Start: July 13, 2012
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share