Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorMurdoch Childrens Research Institute
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Release of Extended Pharmacogenomics Report at Week 1
- Release of Extended Pharmacogenomics Report at Week 13
Treatment groups
880 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov