Clinical trial NCT06902688: Timely Ordering of Pharmacogenetic Testing
Official title: Timely Ordering of Pharmacogenetic Testing in Pediatric Oncology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Machine Learning
Prediction Models
Pediatrics
Precision Medicine
Keywords: precision medicine
machine learning
pharmacogenetics
prediction models
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 275
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients with Pharmacogenetic Testing
timeFrame: Day 1 to 3 months
Secondary outcomes:
measure: Number of patients with pharmacogenetic results available prior to receipt of targeted medication
timeFrame: Day 1
measure: Number of patients who have alteration in medication choice or dose based on pharmacogenetic results
timeFrame: Day 1
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: