NCT05667766Active, not recruiting
Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)
Minimising Adverse Drug Reactions and Verifying Economic Legitimacy - Pharmacogenomics Implementation in Children (MARVEL-PIC)
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
A prospective, open, randomised implementation study in paediatric cancer patients. The study aims to determine whether a personalised approach will result in an overall reduction in clinically relevant adverse drug reactions (ADRs) and to evaluate the economic and quality of life impacts. Participants will be randomised to receive personalised guided prescribing of supportive care therapy (study arm) or standard of care (control arm) for a period of 12 weeks. The follow up period includes prospective patient reporting of symptoms and quality of life through electronically delivered surveys, for a maximum of 12 months.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 441 (actual)
- First submitted
- 19 Dec 2022
- Start date
- 22 Mar 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Murdoch Childrens Research Institute
- Diseases
- Childhood cancers
- NCT number
- NCT05667766
What you commit to
- Study type: Interventional
- Participants enrolled: 441
- From 22 Mar 2023 to the primary completion date, 30 Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Duration of the drug of inclusion total treatment length is planned to be less than one week.
- Patient has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care.
Other illness
- Patient has advanced liver failure.
Age
- Age \> 18 years.
Other
- Patient has a life expectancy estimated to be less than three months by the treating clinical team.
- 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 a glomerular filtration rate of less than 15 mL/min per 1.73m2.
Who the study is looking for
- 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.
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perth Children's Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Women's and Children's Hospital Coordinator of this site? Confirm its status | North Adelaide | Australia | Unknown status |
| The Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.