Actively Recruiting
Led by Murdoch Childrens Research Institute · Updated on 2025-07-18
880
Participants Needed
4
Research Sites
52 weeks
Total Duration
Researchers are evaluating a personalized medicine approach to reduce adverse drug reactions (ADRs) in children and adolescents with a new cancer diagnosis or undergoing first hematopoietic stem cell transplantation (HSCT). This study aims to compare personalized pharmacogenomic guided therapy with standard care to assess the reduction in ADRs, economic impacts, and quality of life changes. The study includes randomization and prospective patient-reported outcomes for symptom and quality of life assessment. Participants will be randomly assigned to either receive personalized supportive care therapy guided by pharmacogenomic testing or standard care. Pharmacogenomic testing covers a broad range of clinically relevant gene variants affecting 27 drugs used in supportive cancer care. Test results are provided at week 4 for the personalized arm and at week 13 for the control arm after the 12-week intervention. Follow-up extends up to 12 months, including patient surveys and health economic data collection. During the study, participants complete symptom surveys using the Paediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) at three points within 12 weeks. Quality of life is assessed using the Child Health Utility 9D (CHU9D) surveys at baseline, week 12, and up to 12 months. Researchers collect health service data to evaluate cost impacts. Semi-structured interviews assess adverse event severity and causality. Data is securely stored with patient confidentiality preserved throughout the study.
CONDITIONS
Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo whole genome sequencing to identify pharmacogenomic variants relevant to cancer supportive care.
1 visit (in-person)
Duration - 12 weeks to 12 months
Participants receive pharmacogenomic-guided prescribing or standard of care prescribing for cancer supportive care medications based on their assigned group.
Follow-up visits occur at 3 time points within 12 weeks; additional assessments may occur up to 12 months
Duration - Up to 12 months
Participants complete quality of life surveys and health economic assessments to evaluate long-term impacts and adverse drug reactions.
3 visits for quality of life surveys over 12 months
Total: 4 locations
1
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
3
The Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
4
Perth Children's Hospital
Nedlands, Washington, Australia, 6009
Actively Recruiting
T
Tayla Stenta
C
Claire Moore
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Rachel Conyers, Andreas Halman, Claire Moore...
https://pubmed.ncbi.nlm.nih.gov/38760050