The Zero Childhood Cancer Program (ZERO) national clinical trial is open to children with high risk cancers (with less than 30% chance of survival) as well as brain/central nervous system cancer, neuroblastoma, sarcoma, renal and thyroid/endocrine cancers. Children with all other cancers will be eligible for enrolment by the end of 2023.
ZERO is available to patients at all eight of Australia’s paediatric oncology centres, as well as Royal Hobart Hospital.
Patients may be enrolled at the time of biopsy or surgery if the diagnosis of a benign or malignant tumour is reasonably suspected and a corresponding cohort for that cancer/tumour type is open. Patients can be at any disease stage (initial diagnosis, refractory/progressive disease and relapse). If the tumour is subsequently found not to be the same tumour type as initial suspected, the patient may move to the appropriate cohort at that time, irrespective of whether that cohort is open for enrolment at that time. This allows patients with any tumour diagnosis to remain on study. Patients may be concurrently enrolled on other clinical trials.
Enrolment of some patients requires discussion with Study Chair or their delegate:
- Patients ≥ 18 years with a paediatric-type cancer
- Patients for whom only a historical sample (obtained >12 months ago) is available
- Patients for whom only an FFPE sample is available
- Patient with a confirmed histiocytic disorder AND for whom molecular profiling may facilitate diagnosis and/or treatment
- Patient with confirmed proliferative vascular tumours AND who meet specific criteria
- Patients for whom a tumour will not be submitted for sequencing and only a germline sample will be available for sequencing
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.
Inclusion criteria for all patients
Signed informed consent for study enrolment from participant aged ≥ 18 years or from parent/guardian of participant aged <18 years.
- Age < 18 years.
Note: Individual patients aged 18 - 25 years old with a paediatric-type 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
- Tumour specimen
Appropriate tumour or lesional samples must be available for analysis (see Section 13.2 for biospecimen requirement). The exception is germline only cohort (Cohort 13).
Age of samples: Tumour sample submitted for enrolment should ideally be representative of current disease or at least collected in the last 12 months. If this is not possible, this must first be discussed with and approved by the Study Chair or delegate prior to enrolment.
Types of samples: Fresh or cryopreserved tumour samples are highly recommended for all cohorts, in particular for confirmed or suspected HR patients. This allows in vitro drug screening to be attempted and generation of patient-derived xenografts. To facilitate the collection of fresh tissues, patients can be consented based on a presumptive diagnosis and have fresh tissue sent to the central laboratory at Children’s Cancer Institute (CCI) for processing while awaiting histological confirmation.
- Germline specimen
Appropriate germline samples must be available to allow for paired tumour-germline WGS. This includes participants who decline return of germline findings. There are specific sample requirements for patients who have undergone an allogeneic bone marrow transplant related.
There is a specific inclusion criteria for individual disease cohorts. Please refer to the ZERO trial protocol for more detail.
Treating clinicians 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.