RecruitingNCT05504772

Precision Medicine for Every Child With Cancer


Sponsor

Australian & New Zealand Children's Haematology/Oncology Group

Enrollment

3,500 participants

Start Date

Dec 16, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

To improve outcomes for childhood cancer patients through the implementation of precision medicine.


Eligibility

Min Age: 0 YearsMax Age: 25 Years

Inclusion Criteria3

  • Age \< 18 years Note: Individual patients aged 19 - 25 years old with a pediatric cancer, e.g., neuroblastoma, may be enrolled after discussion with, and at the discretion of, the Study Chair or their delegate.
  • Life expectancy \>6 weeks at time of enrolment
  • Consent i. Signed and dated informed consent for study enrolment from participant aged ≥ 18 years or from parent/guardian of participant aged \<18 years. ii. Separate signed and dated informed consent for understanding the role of germline testing and choice for the return of germline results.

Interventions

GENETICWhole Genome Sequencing

Each tumor sample will be sequenced and analyzed in parallel with its matched normal (germline DNA from the same patient) to enable the identification of somatic aberrations.

GENETICRNA seq

Results will be used for bioinformatics analysis for fusion transcripts and gene expression.

GENETICDNA Methylation

Genome-wide assessment of DNA methylation will be conducted on all samples where possible.

GENETICTargeted Panel Sequencing

Targeted panel sequencing may be performed: 1. When WGS is not feasible or appropriate, e.g., insufficient DNA from fresh or frozen sample or only Formalin-Fixed Paraffin-Embedded (FFPE) material is available 2. When mosaicism is suspected 3. When indicated for a disease type

GENETICHigh Throughput Sequencing (in vitro)

High throughput drug screening will be attempted for tumors from Cohort 1 (high-risk cancers with survival \<30%) and selected tumor types.

GENETICPatient Derived Xenograft (PDX)(in vivo)

In vivo drug testing in patient derived xenograft (PDX) will be attempted for tumors from Cohort 1 (high-risk cancers) and selected tumor types.

OTHERLiquid Biopsy

Liquid biopsy will be investigated as a non-invasive method for diagnosis of tumors that are difficult to biopsy directly, understanding tumor heterogeneity, monitoring of treatment response, and detection of minimal residual disease (MRD)/relapse in leukemia, solid and CNS tumors.


Locations(11)

Women's and Children's Hospital

Adelaide, Australia

Queensland Children's Hospital

Brisbane, Australia

Royal Hobart Hospital

Hobart, Australia

Monash Children's Hospital

Melbourne, Australia

Royal Children's Hospital

Melbourne, Australia

John Hunter Children's Hospital

Newcastle, Australia

Perth Children's Hospital

Perth, Australia

Sydney Children's Hospital, Randwick

Sydney, Australia

The Children's Hospital at Westmead

Sydney, Australia

Starship Children's Hospital

Auckland, Grafton, New Zealand

Christchurch Hospital

Christchurch, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05504772


Related Trials