Status:
COMPLETED
A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
Conditions:
Adverse Drug Reaction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The INGenious trial will prospectively enroll a total of 6,000 patients, with 2,000 patients assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed, but not tested. ...
Detailed Description
Indiana University School of Medicine and the Indiana University Institute of Personalized Medicine in collaboration with the Eskenazi Health and IUH Systems will be conducting a NIH funded randomized...
Eligibility Criteria
Inclusion
- Patients will be eligible for inclusion if they are prescribed one of the 27 index medications for the first time, defined as there being no recorded prescription in the Eskenazi, Indiana University Health or Indiana Patient Care (INPC) system over the past year. The inclusion criteria that will be adhered to will be:
- Able and willing consent to participation in the trial;
- Adults aged 18 and over;
- Receiving care at Eskenazi Health or Indiana University Health Systems for 1 year or more;
- Prescribed an index medication.
- No documented prescription of the index medication for the past year.
- The study limit of enrollment (500) for that medication has not been reached
- A single tube of whole blood can be obtained, and
- Able to follow study procedures. -
Exclusion
- No subject will be excluded from the study on the basis of ethnicity or race. We will include all minorities.
- Patients will be excluded if they:
- Cannot or do not consent to participate;
- are unable to provide 5cc of whole blood, or it cannot be obtained;
- if they are an employee or student under the supervision of any of the investigators.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2019
Estimated Enrollment :
4465 Patients enrolled
Trial Details
Trial ID
NCT02297126
Start Date
March 1 2015
End Date
May 3 2019
Last Update
January 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eskenazi Health System
Indianapolis, Indiana, United States, 46250