NCT00414115

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Aug 2005Mar 2029

Study Start

First participant enrolled

August 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
22.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

23.6 years

First QC Date

December 19, 2006

Last Update Submit

April 27, 2026

Conditions

Adverse Drug Reaction (ADR)

Keywords

Observational controlled studyGenomic biomarkersAdverse drug reactionIn children OR adults

Outcome Measures

Primary Outcomes (1)

  • Determine the role of genetic and clinical factors in adverse drug reactions to develop risk mitigation strategies.

    December 2018

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children under 19 years who have taken drugs and adults to replicate findings in children

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39500896DERIVED

  • 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.

    PMID: 19507171DERIVED

Related Links

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Bruce Carleton, Pharm. D.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Michael Hayden, MD, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Carleton, PharmD.

CONTACT

604-875-2179bcarleton@popi.ubc.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

August 1, 2005

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

CA(1)