DNA-Guided prescribing may shield young cancer patients from harmful drug reactions
NCT ID NCT05667766
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether analyzing a child's DNA before prescribing supportive care drugs can lower the risk of serious side effects. Children with cancer or those receiving a bone marrow transplant are randomly assigned to get either standard care or prescribing guided by their genetic profile. The study tracks side effects and quality of life for up to a year to see if personalized medicine makes a real difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- whole genome sequencing with pharmacogenomic reporting
- What this could lead to
- If it works, this could make cancer treatment safer for children by tailoring drug choices to their DNA.
- What could go wrong
- The trial is relatively small and focuses on supportive care drugs, not the cancer treatment itself. Benefits may not apply to all children or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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441 people
The number who actually took part.
- Started
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Mar 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \< 18 years * New cancer diagnosis or patient receiving HSCT or patient has a relapsed cancer diagnosis and is starting treatment after more than 6 months without. * Starting treatment with a chemotherapeutic agent that is not single agent oral targeted therapy. * Must also be taking a medication for which there is an established CPIC guideline available. * Parent or patient is able and willing to give consent for patient to take part and be followed up for at least 12 weeks. * Patient is amenable to venepuncture and blood draw (5mL ideally with an absolute minimum requirement of 2.5 mL) or has Whole Genome Sequencing available (WGS). * Patient and/or parent is able and willing to sign an informed consent form. * Patient and/or parent is able to complete Ped-PRO-CTCAE survey in English, Italian or Chinese. * Study enrolment limit has not been reached. Exclusion Criteria: * Age \> 18 years. * Patient has a life expectancy estimated to be less than three months by the treating clinical team. * Duration of the drug of inclusion total treatment length is planned to be less than one week. * Patient and/or parent is unable to consent to the study. * Patient and/or parent is unwilling to take part in the study. * Patient and/or parent is able unable to complete Ped-PRO-CTCAE survey in English, Italian or Chinese. * Patient has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care. * Patient has a glomerular filtration rate of less than 15 mL/min per 1.73m2. * Patient has advanced liver failure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Perth Children's Hospital
Nedlands, Washington, 6009, Australia
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Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
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The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
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Women's and Children's Hospital
North Adelaide, South Australia, 5006, Australia
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