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National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children

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ClinicalTrials.gov Identifier: NCT00414115
Recruitment Status : Recruiting
First Posted : December 21, 2006
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the use of prescription drugs, medical and hospital services and vital statistics between BC participants who experience adverse drug reactions and those who do not.

Study hypothesis: Genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.

Condition or disease
Adverse Drug Reaction (ADR)

Detailed Description:

CPNDS will identify ADR predictive markers by comparing DNA and plasma samples from patients that suffer ADRs with samples from control populations that are stratified by medication type and age. The GATC will obtain its clinical material for ADR patients mainly, from hospital-based active surveillance network across Canada's major hospitals.

1. CPNDS will examine known SNPs in candidate genes related to the ADR (i.e. drug metabolism genes, drug transporter genes, drug target genes, and other disease-specific genes or genes related to the physiological pathway of the ADR.) 2. CPNDS will discover novel ADR predictive SNPs and mutations by sequencing DNA samples from our patient cohorts. CPNDS will also genotype and sequence DNA samples from populations of controls that received the same drugs, but did not suffer ADRs; and a second population of control patients who represent a random sample of the population of known ethnic backgrounds.

Novel ADR predictive SNPs and mutations will be functionally validated by pharmacokinetic approaches applied to time course analysis of drug concentrations for each specific genotype. Pharmacokinetic studies will also be used to determine the drug concentration in patients to characterize possible mechanisms of the ADR, translating into rational approaches to the choice of candidate genes to be examined in the genomic analyses.

The cost-effectiveness of an ADR screening program for the prevention of ADRs in children and adults will be calculated in detailed health-economic studies.

Study Design

Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Canadian Pharmacogenomics Network for Drug Safety
Study Start Date : August 2005
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Determine the role of genetic and clinical factors in adverse drug reactions to develop risk mitigation strategies. [ Time Frame: December 2018 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children under 19 years who have taken drugs and adults to replicate findings in children

Inclusion Criteria:

  • Children under 19 years who have taken drugs.
  • Biological parents of children who have had an ADR.
  • Patients/parents who speak and understand English (except in Quebec).
  • Adults (for validation of findings in children)
Contacts and Locations

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): NCT00414115

Contact: Bruce Carleton, PharmD. 604-875-2179 bcarleton@popi.ubc.ca

Canada, British Columbia
Children's and Women's Health Centre of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Bruce Carleton    604-875-2179    bcarleton@popi.ubc.ca   
Principal Investigator: Bruce Carleton, MD         
Sponsors and Collaborators
University of British Columbia
Genome Canada
Genome British Columbia
Child and Family Research Institute
University of Western Ontario, Canada
Provincial Health Services Authority
Health Canada
Canada Gene Cure
Eli Lilly and Company
Merck Sharp & Dohme Corp.
Canadian Society of Clinical Pharmacology
Canadian Institutes of Health Research (CIHR)
Canada Foundation for Innovation
British Columbia Clinical Genomics Network
Principal Investigator: Bruce Carleton, Pharm. D. University of British Columbia
Principal Investigator: Michael Hayden, MD, Ph.D University of British Columbia
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Carleton, Study Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00414115     History of Changes
Other Study ID Numbers: H04-70358
CW Health Centre of BC
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Bruce Carleton, University of British Columbia:
Observational controlled study
Genomic biomarkers
Adverse drug reaction
In children OR adults

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders