An observational study in Childhood Cancer, Childhood Solid Tumor and Childhood Brain Tumor, sponsored by Sydney Children's Hospitals Network. Active, not recruiting at 8 sites in Australia. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Sydney Children's Hospitals Network · Observational
This is a multicentre prospective study of the feasibility and clinical value of a diagnostic service for identifying therapeutic targets and recommending personalised treatment for children and adolescents with high-risk cancer.
This is a multicentre study conducted under the Zero Childhood Cancer Program. The study will be enrolling patients under the age of 21 with high-risk cancer over 3 years from cancer centres in Australia. Patient's cancer cells will be tested for genetic abnormalities (mutations) and undergoing drug testing in highly specialised laboratories. A Multidisciplinary Tumour Board comprising of oncologists, clinical geneticists and scientists will then discuss the results of each case and determine whether a personalised medicine recommendation can be made. A report describing the results and Tumour Board recommendation (if any) will be provided to the patient's treating doctor. It is always at the discretion of the treating doctor whether to alter the patient's management based on the information arising from this research project.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 550 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Sydney Children's Hospitals Network is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Paediatric patients who are being treated for high-risk cancer in Australia
Inclusion criteria (all must be met)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Expected survival \< 30%
Diagnostic Test: Molecular profiling and drug testing
1. Laboratory analysis including: A. Tumour molecular profiling: targeted whole exon variant analysis, whole genome (DNA) and transcriptome (RNA) sequencing, methylation analysis, proteomics analysis, immunohistochemistry B. In vitro high-throughput drug sensitivity testing C. In vivo drug testing using patient-derived xenograft (PDX) models D. Liquid biopsies 2. Multi-disciplinary Tumour Board case discussion 3. Recommendation of personalised therapy
Personalized medicine recommendation
Proportion of patients for whom personalized medicine recommendation can be made using a comprehensive diagnostic platform within a clinically relevant timeframe
Time frame: 5 years
Tumor samples with actionable molecular alterations
Proportion of tumor samples found to have actionable molecular alterations
Time frame: 5 years
Successfully conducted in vitro high throughput drug screening and in vivo drug sensitivity testing
Proportion of tumours where in vitro high throughput drug screening and in vivo drug sensitivity testing can be successfully performed
Time frame: 5 years
Identification of potential treatment by in vitro or in vivo drug screening
Proportion of tumors for which a potential treatment option is identified by in vitro or in vivo drug screening
Time frame: 5 years
Reporting turnaround time
Number of weeks from enrollment to issuing a report to the treating clinician
Time frame: 5 years
Patients receiving the recommended personalized therapy
Proportion of patients who subsequently receive the recommended personalized therapy
Time frame: 5 years
Barriers or reasons for patients not receiving the recommended personalized therapy
Description of the barriers or reasons for patients not receiving the recommended personalized therapy
Time frame: 5 years
Impact of personalized therapy on progression-free survival
Time interval from enrollment until disease progression or death for patients who have received personalized therapy versus those who have not
Time frame: Up to 5 years
Impact of personalized therapy on overall survival
Time interval from enrollment until death for patients who have received personalized therapy versus those who have not
Time frame: Up to 5 years
Started Sep 2017 (actual). Primary completion is estimated for Aug 2028, 131 months after the start.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 131 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Sydney Children's Hospitals Network