Precision Medicine for Every Child With Cancer

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Genetic, Other
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Women's and Children's Hospital
RECRUITING
Adelaide
Queensland Children's Hospital
RECRUITING
Brisbane
Royal Hobart Hospital
RECRUITING
Hobart
Monash Children's Hospital
RECRUITING
Melbourne
Royal Children's Hospital
RECRUITING
Melbourne
John Hunter Children's Hospital
RECRUITING
Newcastle
Perth Children's Hospital
RECRUITING
Perth
Sydney Children's Hospital, Randwick
RECRUITING
Sydney
The Children's Hospital at Westmead
RECRUITING
Sydney
New Zealand
Starship Children's Hospital
RECRUITING
Auckland
Christchurch Hospital
NOT_YET_RECRUITING
Christchurch
Contact Information
Primary
National Study Coordinator
SCHN-ZERO2@health.nsw.gov.au
+61 2 9382 3102
Time Frame
Start Date: 2022-12-16
Estimated Completion Date: 2030-07
Participants
Target number of participants: 3500
Treatments
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.
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
Primary central nervous system (CNS) tumours
Patient is suspected or confirmed to have a primary CNS tumor, including low and high-grade tumors
Neuroblastoma
Patient is suspected or confirmed to have neuroblastoma 4A: HR neuroblastoma at diagnosis 4B: Non-HR neuroblastoma
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)
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)
Lymphomas
Patient is suspected or confirmed to have a lymphoma
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)
Renal tumors
Patient is suspected or confirmed to have a renal tumor Includes clear cell sarcoma of kidney
Hepatic and biliary tree tumors
Patient is suspected or confirmed to have a liver or biliary tree tumor
Thyroid and endocrine tumors
Patient is suspected or confirmed to have a thyroid or endocrine cancer
Other tumors
Patient is suspected or confirmed to have a tumor which does not fit into any of the above
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.
Related Therapeutic Areas
Sponsors
Leads: Australian & New Zealand Children's Haematology/Oncology Group
Collaborators: Minderoo Foundation, Children's Cancer Institute (CCI), Medical Research Future Fund

This content was sourced from clinicaltrials.gov

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