Trial Title:
Precision Medicine for Every Child With Cancer
NCT ID:
NCT05504772
Condition:
Childhood Cancer
Childhood Solid Tumor
Childhood Brain Tumor
Childhood Leukemia
Refractory Cancer
Relapsed Cancer
Conditions: Keywords:
children
precision medicine
personalised medicine
molecular profiling
pediatric
paediatric
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Whole Genome Sequencing
Description:
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.
Arm group label:
Acute lymphoblastic leukemia (ALL)
Arm group label:
Acute myeloid leukemia, myelodysplastic syndrome and other leukemias not classified as ALL
Arm group label:
Germline only
Arm group label:
Hepatic and biliary tree tumors
Arm group label:
High-risk cancers
Arm group label:
Lymphomas
Arm group label:
Neuroblastoma
Arm group label:
Other tumors
Arm group label:
Primary central nervous system (CNS) tumours
Arm group label:
Rare tumors
Arm group label:
Renal tumors
Arm group label:
Sarcomas
Arm group label:
Thyroid and endocrine tumors
Intervention type:
Genetic
Intervention name:
RNA seq
Description:
Results will be used for bioinformatics analysis for fusion transcripts and gene
expression.
Arm group label:
Acute lymphoblastic leukemia (ALL)
Arm group label:
Acute myeloid leukemia, myelodysplastic syndrome and other leukemias not classified as ALL
Arm group label:
Germline only
Arm group label:
Hepatic and biliary tree tumors
Arm group label:
High-risk cancers
Arm group label:
Lymphomas
Arm group label:
Neuroblastoma
Arm group label:
Other tumors
Arm group label:
Primary central nervous system (CNS) tumours
Arm group label:
Rare tumors
Arm group label:
Renal tumors
Arm group label:
Sarcomas
Arm group label:
Thyroid and endocrine tumors
Intervention type:
Genetic
Intervention name:
DNA Methylation
Description:
Genome-wide assessment of DNA methylation will be conducted on all samples where
possible.
Arm group label:
Acute lymphoblastic leukemia (ALL)
Arm group label:
Acute myeloid leukemia, myelodysplastic syndrome and other leukemias not classified as ALL
Arm group label:
Germline only
Arm group label:
Hepatic and biliary tree tumors
Arm group label:
High-risk cancers
Arm group label:
Lymphomas
Arm group label:
Neuroblastoma
Arm group label:
Other tumors
Arm group label:
Primary central nervous system (CNS) tumours
Arm group label:
Rare tumors
Arm group label:
Renal tumors
Arm group label:
Sarcomas
Arm group label:
Thyroid and endocrine tumors
Intervention type:
Genetic
Intervention name:
Targeted Panel Sequencing
Description:
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
Arm group label:
Acute lymphoblastic leukemia (ALL)
Arm group label:
Acute myeloid leukemia, myelodysplastic syndrome and other leukemias not classified as ALL
Arm group label:
Germline only
Arm group label:
Hepatic and biliary tree tumors
Arm group label:
High-risk cancers
Arm group label:
Lymphomas
Arm group label:
Neuroblastoma
Arm group label:
Other tumors
Arm group label:
Primary central nervous system (CNS) tumours
Arm group label:
Rare tumors
Arm group label:
Renal tumors
Arm group label:
Sarcomas
Arm group label:
Thyroid and endocrine tumors
Intervention type:
Genetic
Intervention name:
High Throughput Sequencing (in vitro)
Description:
High throughput drug screening will be attempted for tumors from Cohort 1 (high-risk
cancers with survival <30%) and selected tumor types.
Arm group label:
High-risk cancers
Intervention type:
Genetic
Intervention name:
Patient Derived Xenograft (PDX)(in vivo)
Description:
In vivo drug testing in patient derived xenograft (PDX) will be attempted for tumors from
Cohort 1 (high-risk cancers) and selected tumor types.
Arm group label:
High-risk cancers
Intervention type:
Other
Intervention name:
Liquid Biopsy
Description:
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.
Arm group label:
Acute lymphoblastic leukemia (ALL)
Arm group label:
Acute myeloid leukemia, myelodysplastic syndrome and other leukemias not classified as ALL
Arm group label:
Germline only
Arm group label:
Hepatic and biliary tree tumors
Arm group label:
High-risk cancers
Arm group label:
Lymphomas
Arm group label:
Neuroblastoma
Arm group label:
Other tumors
Arm group label:
Primary central nervous system (CNS) tumours
Arm group label:
Rare tumors
Arm group label:
Renal tumors
Arm group label:
Sarcomas
Arm group label:
Thyroid and endocrine tumors
Summary:
To improve outcomes for childhood cancer patients through the implementation of precision
medicine.
Detailed description:
Through the pilot TARGET and national PRISM trials the feasibility and benefits of using
comprehensive molecular profiling and preclinical drug testing in real time for high-risk
(HR) patients has been demonstrated. However, the role of precision medicine, especially
in facilitating diagnosis and risk stratification in non-HR childhood cancers has not
been studied. Integrative tumor-germline whole genome sequencing (WGS) analysis has the
potential to advance our understanding of cancer predisposition. In this study, the ZERO
platform will be extended to all children with cancer in Australia and New Zealand,
evaluating the benefits of precision medicine in different childhood cancer types and
risk groups.
Criteria for eligibility:
Study pop:
Patients <18 years of age with a diagnosis of tumor or cancer Patients aged 19 - 25 years
with a diagnosis of a pediatric tumor or cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. 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.
2. Life expectancy >6 weeks at time of enrolment
3. 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.
Gender:
All
Minimum age:
0 Years
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's and Children's Hospital
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Suzanne Milne
Email:
suzanne.milne@sa.gov.au
Facility:
Name:
Queensland Children's Hospital
Address:
City:
Brisbane
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Natasha Brown
Email:
natasha.brown@health.qld.gov.au
Facility:
Name:
Royal Hobart Hospital
Address:
City:
Hobart
Country:
Australia
Status:
Recruiting
Contact:
Last name:
David Nolan
Email:
david.nolan@ths.tas.gov.au
Facility:
Name:
Monash Children's Hospital
Address:
City:
Melbourne
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Amanda St John
Email:
Amanda.StJohn@monashhealth.org
Facility:
Name:
Royal Children's Hospital
Address:
City:
Melbourne
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kahlia Fox
Email:
clinicaltrialsmanager@rch.org.au
Facility:
Name:
John Hunter Children's Hospital
Address:
City:
Newcastle
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Rebecca Jensen
Email:
Rebecca.Jensen@health.nsw.gov.au
Facility:
Name:
Perth Children's Hospital
Address:
City:
Perth
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jennifer McConnell
Email:
jennifer.mcconnell@health.wa.gov.au
Facility:
Name:
Sydney Children's Hospital, Randwick
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sandra Montez
Email:
Sandra.Montez@health.nsw.gov.au
Facility:
Name:
The Children's Hospital at Westmead
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jun Christian
Email:
jun.christian@health.nsw.gov.au
Facility:
Name:
Starship Children's Hospital
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Sarah Hunter
Email:
SHunter@adhb.govt.nz
Facility:
Name:
Christchurch Hospital
Address:
City:
Christchurch
Zip:
8011
Country:
New Zealand
Status:
Not yet recruiting
Contact:
Last name:
Kirstie Copeland
Email:
Kirstie.copeland@cdhb.health.nz
Start date:
December 16, 2022
Completion date:
July 2030
Lead sponsor:
Agency:
Australian & New Zealand Children's Haematology/Oncology Group
Agency class:
Other
Collaborator:
Agency:
Children's Cancer Institute (CCI)
Agency class:
Other
Collaborator:
Agency:
Minderoo Foundation
Agency class:
Other
Collaborator:
Agency:
Medical Research Future Fund
Agency class:
Other
Source:
Australian & New Zealand Children's Haematology/Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504772
