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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Adverse Drug Reaction (ADR)

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Other
Official Title: Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
DNA samples will be retained for genomic analyses.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249375


Contacts
Layout table for location contacts
Contact: Bruce Carleton, PharmD. 604-875-2179 bcarleton@popi.ubc.ca

Locations
Layout table for location information
Canada, British Columbia
Children's and Women's Health Centre of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Bruce Carleton, PharmD.    604-875-2179    bcarleton@popi.ubc.ca   
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
University of British Columbia
Genome British Columbia
Genome Canada
Dynacare Laboratories, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bruce Carleton, Director, Pharmaceutical Outcomes Programme, University of British Columbia
ClinicalTrials.gov Identifier: NCT04249375    
Other Study ID Numbers: H18-01383
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: November 30, 2023
Last Verified: November 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruce Carleton, University of British Columbia:
Pharmacogenomics
Pediatrics
Adverse Drug Reactions
Additional relevant MeSH terms:
Layout table for MeSH terms
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders