The current Zero Childhood Cancer Program (ZERO) national clinical trial will remain open until the opening of the new trial. The current trial is open to children anywhere in Australia with high-risk or rare cancers and to date nearly 600 children have been enrolled.
In 2021, a new five-year national clinical trial will be launched. The new trial will be expanded to include children with lower risk cancers – firstly those with medium-risk, then those with standard-risk cancer. By the end of 2023, it is our aim that all Australian children and young people with cancer will be able to participate in ZERO at diagnosis.
Patients with a suspected or confirmed diagnosis of high-risk malignancy can be registered for ZERO.
- For patients with a confirmed diagnosis at registration, enrolment will occur following confirmation that all eligibility criteria are met, and approval has been granted by the Study Chair or delegate.
- For patients where there is a reasonable clinical suspicion of a high-risk malignancy, patients can be registered during the work-up period before diagnosis and prognosis is established. Fresh tissue samples can be sent to Children’s Cancer Institute for initial processing following registration. Enrolment will occur following confirmation that all eligibility criteria are met, and approval has been given by the Study Chair or delegate. Non-high-risk samples will be banked for future approved research.
The following eligibility criteria apply to patient selection for specimen collection and analysis only. All eligibility criteria must be met prior to enrolment.
At enrolment, patients will be treated with therapy selected by their clinician. Patients may be concurrently enrolled on other clinical trials. Treatment with recommended therapy will remain at the discretion of the treating physician.
Patients with high risk cancers:
1. Age ≤ 21 years: Individual patients > 21 years with a paediatric-type cancer (e.g. neuroblastoma) may be enrolled after discussion with, and at the discretion of, the Study Chair or delegate.
2. Diagnosis: Histologic diagnosis of high-risk malignancy, defined as:
- expected overall survival < 30% based on current literature on the specific cancer; OR
- where standard therapy would result in severe and unacceptable morbidity (such as an infantile sarcoma where definitive surgery would require amputation).
Please note this does not include high-risk neuroblastoma at diagnosis.
3. Specimen: Appropriate tissue samples are available for analysis. Tissue sample can be obtained as part of clinical care or (with consent) for the sole purpose of study enrolment.
4. Life expectancy: > 6 weeks.
5. Consent: Patients are either capable of giving informed consent, or have a parent or guardian capable of giving consent, and are willing to comply with all study requirements, including tissue sampling and all required follow-up assessments.
Patients with rare cancers (PRISM Rare Cancers Cohort):
1. Age: ≤ 18 years
2. Diagnosis: Either:
- a rare cancer of uncertain prognosis with no established treatment strategy; OR
- a tumour where histopathological examination has not been able to establish a diagnosis.
3. Specimen: Appropriate tissue samples are available for analysis
4. Consent: Written informed consent
5. Approval: All patients must first be discussed and approved by the Study Chair or their delegate prior to enrolment on the Rare Cancers Cohort (Cohort B).
The investigators at each participating site will be responsible for discussing the risks and benefits of enrolment on this study with the patient or parent/legal guardian. Informed consent must be signed by the patient or parent/guardian and dated by an investigator at the relevant site at the time of registration. Patients or parents will be given the choice of opting out of being informed of reportable germline mutations, and of participating in the psychosocial sub-study or the familial cancer predisposition sub-study.
Consent to participate in the study or sub-studies can be withdrawn at any time.