Adverse Drug Reaction (ADR)NCT00414115
National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
An observational study of Adverse Drug Reaction (ADR), run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Reaction (ADR)
- How many people
- 7,000 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Mar 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children under 19 years who have taken drugs and adults to replicate findings in children
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
Bruce Carleton, 604-875-2179, bcarleton@popi.ubc.ca
Bruce Carleton, MD
About this study
Official title: Canadian Pharmacogenomics Network for Drug Safety
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.
Read the 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.
- 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
- Adverse Drug Reaction (ADR)
- Keywords
- Observational controlled study, Genomic biomarkers, Adverse drug reaction, In children OR adults
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the role of genetic and clinical factors in adverse drug reactions to develop risk mitigation strategies.
Measured: December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startAug 2005
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug Reaction (ADR)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Genome Canada, Genome British Columbia, Child and Family Research Institute, Western University, Canada, Provincial Health Services Authority British Columbia, Health Canada, Canada Gene Cure, Eli Lilly and Company, Pfizer, Merck Sharp & Dohme LLC, Canadian Society of Clinical Pharmacology, Canadian Institutes of Health Research (CIHR), Canada Foundation for Innovation, British Columbia Clinical Genomics Network
- Responsible party
- Principal investigator, Bruce Carleton, University of British Columbia
- Investigators
- Bruce Carleton, Pharm. D., Principal investigator, University of British ColumbiaMichael Hayden, MD, Ph.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414115
- Sponsor's protocol ID
- H24-00656 (formerly H04-70358)
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2006
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39500896Carleton 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.
PubMed 19507171