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

This study is currently recruiting participants.

Verified by University of British Columbia, September 2008

First Received: December 19, 2006 Last Updated: September 2, 2008 History of Changes

Sponsor:	University of British Columbia
Collaborators:	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 Pfizer Merck Janssen-Ortho LLC Canadian Society of Clinical Pharmacology International Business Machines (IBM)
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00414115

Purpose

The purpose of the study is (1) to identify and collect samples from children who take drugs and have adverse drug reactions AND children 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
Adverse Drug Reaction (ADR)

Study Type:	Observational
Study Design:	Cohort
Official Title:	GATC: Genotype Specific Approaches to Therapy in Childhood

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Estimated Enrollment:	5000
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2009

Detailed Description:

The GATC 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.

The GATC will examine 1900 known functional SNPs in candidate genes related to the ADR (i.se. Drug metabolism genes, drug transporter genes, drug target genes, and other disease-specific genes or genes related to the physiological pathway of the ADR.)
The GATC will discover novel ADR predictive SNPs and mutations by sequencing ADR-specific related genes in our patient cohorts. The GATC will sequence a subset of 20-40 genes per patient from a selection of 200 genes. The GATC 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 will be calculated in detailed health-economic studies.

Eligibility

Ages Eligible for Study:	up to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Children under 19 years who have taken drugs

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414115

Contacts

Contact: Anne Smith

604-875-3502

asmith@popi.ubc.ca

Locations

Canada, British Columbia
Children's and Women's Health Centre of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Anne Smith 604-875-3502 asmith@popi.ubc.ca
Principal Investigator: Bruce Carleton, MD

Sponsors and Collaborators

University of British Columbia

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

Pfizer

Merck

Janssen-Ortho LLC

Canadian Society of Clinical Pharmacology

International Business Machines (IBM)

Investigators

Principal Investigator:	Bruce Carleton, MD	University of British Columbia
Principal Investigator:	Michael Hayden, Ph.D	University of British Columbia

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of British Columbia ( Drs. Bruce Carleton and Michael Hayden )
Study ID Numbers:	C04-0358, CW Health Centre of BC, W04-0138
Study First Received:	December 19, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00414115 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Observational controlled study
Genomic biomarkers
Adverse drug reaction
In children

Additional relevant MeSH terms:

Drug Toxicity
Poisoning
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 08, 2010