The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249375
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : November 30, 2023
Sponsor:
Collaborators:
Genome British Columbia
Genome Canada
Dynacare Laboratories, Inc.
Information provided by (Responsible Party):
Bruce Carleton, University of British Columbia

Tracking Information
First Submitted Date September 24, 2019
First Posted Date January 30, 2020
Last Update Posted Date November 30, 2023
Actual Study Start Date February 20, 2020
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2020)		 150 participants on analgesics, anti-infectives and psychotropics will be given pharmacogenomic recommendations for the risk of gene related adverse events prior to or during treatment. [ Time Frame: June 2020 ]
We will be able to determine the barriers and facilitators of the implementation of the pharmacogenomic service in a health care facility. This will be done by using standardized questionnaires after each pharmacogenomic report is issued. The prescriber and the patient will both answer questions about the utility of the genetic results, the format of the report and the clarity of the content. Results will be recorded and summarized every 25 patients in order to improve the service and the recommendations through the study.
Original Primary Outcome Measures
 (submitted: January 29, 2020)		 150 participants on analgesics, anti-infectives and psychotropics will be given pharmacogenomic recommendations for the risk of gene related adverse events prior to or during treatment. [ Time Frame: June 2020 ]
We will be able to determine the barriers and facilitators of the implementation of the pharmacogenomic service in a health care facility.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
Official Title Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
Brief Summary

This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications.

We will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.
Detailed Description

The specific objectives are to:

  1. Implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making.
  2. Develop data collection forms to collect necessary patient information from the prescribing physicians.
  3. Develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families.
  4. Determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA samples will be retained for genomic analyses.
Sampling Method Non-Probability Sample
Study Population Any individual who is currently on an analgesic, antibiotic and/or mental health medication that is part of the panels.
Condition Adverse Drug Reaction (ADR)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 29, 2020)		 150
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants will be enrolled if they can benefit from pharmacogenomic testing. This means their physician is considering the use of a drug that is part of the panels (analgesics, antibiotics, and mental health medication) or they are already using one.

Exclusion Criteria:

  • Patients who do not speak or understand English.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Bruce Carleton, PharmD. 604-875-2179 bcarleton@popi.ubc.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04249375
Other Study ID Numbers H18-01383
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Bruce Carleton, University of British Columbia
Original Responsible Party Same as current
Current Study Sponsor University of British Columbia
Original Study Sponsor Same as current
Collaborators
  • Genome British Columbia
  • Genome Canada
  • Dynacare Laboratories, Inc.
Investigators Not Provided
PRS Account University of British Columbia
Verification Date November 2023