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RECRUITING
NCT05667766
NA

Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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