Skip to content

Timely Ordering of Pharmacogenetic Testing

Timely Ordering of Pharmacogenetic Testing in Pediatric Oncology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06902688
Enrollment
275
Registered
2025-03-30
Start date
2025-06-10
Completion date
2027-06-10
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Machine Learning, Pediatrics, Precision Medicine, Prediction Models

Keywords

precision medicine, machine learning, pharmacogenetics, prediction models, pediatrics

Brief summary

The goal of this trial is to learn if a machine learning (ML) model can help optimize drug therapy in the pediatric population. The main question\[s\] it aims to answer are whether a machine learning model predicting receipt of a targeted medication within the next three months: * Increases the offering of pharmacogenetic testing prior to receipt of a targeted medication * Increases the number of patients with pharmacogenetic results prior to receipt of a targeted medication * Increases the number of patients who have alteration in medication choice or dose based on pharmacogenetic results This trial only focuses on the prediction and provision of participants with a high-risk of receiving a medication with a pharmacogenetic indication in the next three months.

Detailed description

This study aims to evaluate the effectiveness of a ML model in predicting patients at high risk of requiring a "targeted medication" within the next three months. A machine learning model will predict, the morning following admission to any inpatient service, whether there will be receipt of a targeted medication within the next three months. The research team will be notified regarding eligible patients each morning, and the research team or pharmacogenomics team will approach the patient's primary care team as applicable. By leveraging ML, this study seeks to enhance the identification of patients who would benefit from such medications in a timely and resource-efficient manner. The study team identified specific medications as indications for pharmacogenetic testing based on prevalence and level of evidence for modifying prescribing practices. These pre-selected medications are referred to as "targeted medications" and are as follows: azathioprine, brivaracetam, clobazam, clopidogrel, flecainide, phenytoin, tacrolimus, voriconazole and warfarin. Only systemically administered (oral, subcutaneous, intramuscular or intravenous) medications or prescriptions (e.g. not topical, intrathecal or intravitreal) are included. Phenytoin was only considered if given orally (to exclude emergency administration without a plan for ongoing treatment). Pharmacogenetic testing will be offered to participants and conducted as addressed in an associated pharmacogenetic testing protocol (REB# 1000053445 PI: Iris Cohn).

Interventions

A ML-based model will predict and identify participants that are at high-risk of receiving a targeted medication within three months after their hospital admission date.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* Inpatient at The Hospital for Sick Children * Between 6 months to 18 years old

Exclusion criteria

* Prior pharmacogenetic testing and/or prior receipt of a targeted medication * Current Intensive Care Unit (ICU) admission * Expected hospital discharge is prior to midnight on the day of admission

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients with Pharmacogenetic TestingDay 1 to 3 monthsThe primary outcome will be the proportion of patients with pharmacogenetic testing offered among those who receive a medication with a pharmacogenetic indication within three months of prediction time. Testing must be offered prior to receipt of the first targeted medication.

Secondary

MeasureTime frameDescription
Number of patients with pharmacogenetic results available prior to receipt of targeted medicationDay 1Measured via chart review
Number of patients who have alteration in medication choice or dose based on pharmacogenetic resultsDay 1Measured via chart review

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORLillian Sung, MD, PhD

The Hospital for Sick Children

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026