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DNA-Guided prescribing may shield young cancer patients from harmful drug reactions

NCT ID NCT05667766

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

441 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

Up to 18 years

Sex

Anyone

Healthy volunteers

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

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

  • Perth Children's Hospital

    Nedlands, Washington, 6009, Australia

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031, Australia

  • The Royal Children's Hospital

    Parkville, Victoria, 3052, Australia

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006, Australia

More trials for these conditions

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