National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
NCT ID: NCT00414115
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7000 participants
OBSERVATIONAL
2005-08-31
2029-03-31
Brief Summary
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Study hypothesis: Genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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)
ALL
Yes
Sponsors
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Genome Canada
OTHER
Genome British Columbia
INDUSTRY
Child and Family Research Institute
OTHER
Western University, Canada
OTHER
Provincial Health Services Authority
OTHER
Health Canada
OTHER_GOV
Canada Gene Cure
UNKNOWN
Eli Lilly and Company
INDUSTRY
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Canadian Society of Clinical Pharmacology
UNKNOWN
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canada Foundation for Innovation
OTHER
British Columbia Clinical Genomics Network
OTHER
University of British Columbia
OTHER
Responsible Party
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Bruce Carleton
Study Principal Investigator
Principal Investigators
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Bruce Carleton, Pharm. D.
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Michael Hayden, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Mufti K, Cordova M, Scott EN, Trueman JN, Lovnicki JM, Loucks CM, Rassekh SR, Ross CJD, Carleton BC; Canadian Pharmacogenomics Network for Drug Safety Consortium. Genomic variations associated with risk and protection against vincristine-induced peripheral neuropathy in pediatric cancer patients. NPJ Genom Med. 2024 Nov 5;9(1):56. doi: 10.1038/s41525-024-00443-7.
Carleton B, Poole R, Smith M, Leeder J, Ghannadan R, Ross C, Phillips M, Hayden M. Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals. Pharmacoepidemiol Drug Saf. 2009 Aug;18(8):713-21. doi: 10.1002/pds.1772.
Related Links
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Related Info
Related Info
Other Identifiers
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CW Health Centre of BC
Identifier Type: -
Identifier Source: secondary_id
W04-0138
Identifier Type: -
Identifier Source: secondary_id
H04-70358
Identifier Type: -
Identifier Source: org_study_id
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