Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3500 participants
OBSERVATIONAL
2022-12-16
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High-risk cancers
One of the following two criteria must be met:
1. Confirmed or suspected high-risk malignancy defined as expected overall survival \< 30% based on current literature for the specific cancer
2. Cancers for which standard therapy would result in unacceptable and severe morbidity (e.g., infantile fibrosarcoma where definitive surgery would require amputation of limb) Note: This does not include HR neuroblastoma at diagnosis as this group of patients have an overall survival ≥30% and belongs to Cohort 4A.
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
High 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.
Patient 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.
Liquid 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.
Rare tumors
At least one of the following three criteria must be met:
1. A rare tumor of uncertain prognosis due to rarity of disease
2. A rare tumor with no established treatment strategy
3. A cancer where routine histopathological examination has not been able to establish a diagnosis
4. Confirmed histiocytic disorder AND molecular profiling may facilitate diagnosis and/or treatment
5. Confirmed proliferative vascular or lymphatic malformation AND has failed conventional treatment, e.g., surgery or embolization, OR no appropriate treatment is available AND the disease is organ, limb or life threatening, or debilitating
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Primary central nervous system (CNS) tumours
Patient is suspected or confirmed to have a primary CNS tumor, including low and high-grade tumors
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Neuroblastoma
Patient is suspected or confirmed to have neuroblastoma 4A: HR neuroblastoma at diagnosis 4B: Non-HR neuroblastoma
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Acute myeloid leukemia, myelodysplastic syndrome and other leukemias not classified as ALL
Patient is confirmed by flow cytometry to have acute myeloid leukemia (AML) or other leukemias (Note: Verbal confirmation of flow cytometry result is adequate for enrolment)
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Acute lymphoblastic leukemia (ALL)
Patient is confirmed to have acute lymphoblastic leukemia by flow cytometry (Note: Verbal confirmation of flow cytometry result is adequate for enrolment)
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Lymphomas
Patient is suspected or confirmed to have a lymphoma
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Sarcomas
Patient is suspected or confirmed to have a sarcoma Includes gastrointestinal stromal tumour (GIST), malignant peripheral nerve sheath tumour (MPNST), desmoplastic small round cell tumour (DSRCT)
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Renal tumors
Patient is suspected or confirmed to have a renal tumor Includes clear cell sarcoma of kidney
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Hepatic and biliary tree tumors
Patient is suspected or confirmed to have a liver or biliary tree tumor
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Thyroid and endocrine tumors
Patient is suspected or confirmed to have a thyroid or endocrine cancer
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Other tumors
Patient is suspected or confirmed to have a tumor which does not fit into any of the above
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Germline only
One of the following two criteria must be met:
1. Patients whose submitted tumor sample could not yield sufficient DNA for any molecular analysis AND participants/parents have consented to return of germline findings.
2. Patients who do not have appropriate tumor sample to be submitted for molecular profiling may be considered for germline only analysis. Obtaining tumor samples wherever possible will be encouraged.
Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
Liquid 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.
Interventions
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Whole 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.
RNA seq
Results will be used for bioinformatics analysis for fusion transcripts and gene expression.
DNA Methylation
Genome-wide assessment of DNA methylation will be conducted on all samples where possible.
Targeted 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
High 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.
Patient 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.
Liquid 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.
Eligibility Criteria
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Inclusion Criteria
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.
0 Years
25 Years
ALL
No
Sponsors
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Children's Cancer Institute (CCI)
UNKNOWN
Minderoo Foundation
UNKNOWN
Medical Research Future Fund
OTHER
Australian & New Zealand Children's Haematology/Oncology Group
OTHER
Responsible Party
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Principal Investigators
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David Ziegler
Role: PRINCIPAL_INVESTIGATOR
SCHN
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZERO2
Identifier Type: -
Identifier Source: org_study_id
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