NCT05667766 Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)
| NCT ID | NCT05667766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 880 participants |
| Start Date | 2023-03-22 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 880 participants in total. It began in 2023-03-22 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
A/Prof Rachel Conyers
PRINCIPAL INVESTIGATOR
The Royal Children's Hospital/Murdoch Children's Research Institute
Frequently Asked Questions
Who can join the NCT05667766 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05667766 currently recruiting?
Yes, NCT05667766 is actively recruiting participants. Contact the research team at pharmaco.genomics@mcri.edu.au for enrollment information.
Where is the NCT05667766 trial being conducted?
This trial is being conducted at Randwick, Australia, North Adelaide, Australia, Parkville, Australia, Nedlands, Australia.
Who is sponsoring the NCT05667766 clinical trial?
NCT05667766 is sponsored by Murdoch Childrens Research Institute. The principal investigator is A/Prof Rachel Conyers at The Royal Children's Hospital/Murdoch Children's Research Institute. The trial plans to enroll 880 participants.