Minimising Adverse Drug Reactions and Verifying Economic Legitimacy - Pharmacogenomics Implementation in Children (MARVEL-PIC)
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.
• 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.