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NCT Number: NCT06902688

Timely Ordering of Pharmacogenetic Testing

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.

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location status: Recruiting

Location contact

Lillian Sung, MD, PhD

CONTACT

[email protected]

4168135287

Lillian Sung, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ML-based intervention

Other

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.

Primary outcomes

  1. Proportion of Patients with Pharmacogenetic Testing

    Time frame: Day 1 to 3 months

    The 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 outcomes

  1. Number of patients with pharmacogenetic results available prior to receipt of targeted medication

    Time frame: Day 1

    Measured via chart review

  2. Number of patients who have alteration in medication choice or dose based on pharmacogenetic results

    Time frame: Day 1

    Measured via chart review

Study contacts

Contact information is provided by the study sponsor or research team.

Agata Wolochacz, BMSc

CONTACT

[email protected]

4168137654 ext. 309976

Lillian Sung, MD, PhD

CONTACT

[email protected]

4168135287

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Timely Ordering of Pharmacogenetic Testing in Pediatric Oncology

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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