Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
NCT05667766

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

Led by Murdoch Childrens Research Institute · Updated on 2025-07-18

880

Participants Needed

4

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age less than 18 years
  • New cancer diagnosis, or receiving HSCT, or relapsed cancer starting treatment after more than 6 months without treatment
  • Starting treatment with a chemotherapeutic agent that is not single agent oral targeted therapy
  • Taking a medication with an established CPIC guideline available
  • Parent or patient able and willing to give consent and be followed up for at least 12 weeks
  • Patient amenable to venepuncture and blood draw or has Whole Genome Sequencing available
  • Patient and/or parent able and willing to sign an informed consent form
  • Patient and/or parent able to complete Ped-PRO-CTCAE survey in English, Italian, or Chinese
  • Study enrolment limit has not been reached
Not Eligible

You will not qualify if you...

  • Age greater than 18 years
  • Life expectancy estimated to be less than three months by treating clinical team
  • Planned total treatment length of the drug of inclusion is less than one week
  • Patient and/or parent unable or unwilling to consent to or take part in the study
  • Patient and/or parent unable to complete Ped-PRO-CTCAE survey in English, Italian, or Chinese
  • Patient has existing impaired hepatic or renal function requiring lower dose or alternate drug as part of routine care
  • Patient has glomerular filtration rate less than 15 mL/min per 1.73m2
  • Patient has advanced liver failure

AI-Screening

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Trial Site Locations

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

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Research Team

T

Tayla Stenta

CONTACT

C

Claire Moore

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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