Clinical Research Directory
Browse clinical research sites, groups, and studies.
Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)
Sponsor: Murdoch Childrens Research Institute
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.
Official title: Minimising Adverse Drug Reactions and Verifying Economic Legitimacy - Pharmacogenomics Implementation in Children (MARVEL-PIC)
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
880
Start Date
2023-03-22
Completion Date
2027-08
Last Updated
2025-07-18
Healthy Volunteers
No
Conditions
Interventions
Release of Extended Pharmacogenomics Report at Week 1
Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) by Week 1. Whole genome sequencing on a broader number of actionable variants as per international guidelines for cancer supportive care (identical to study arm) will be reported on at Week 13.
Release of Extended Pharmacogenomics Report at Week 13
Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) and reporting of a broader number of actionable pharmacogenomic variants as per international guidelines for cancer supportive care reported on by Week 1.
Locations (4)
Sydney Children's Hospital
Randwick, New South Wales, Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Washington, Australia