Trials / Active Not Recruiting
Active Not RecruitingNCT03336931
PRecISion Medicine for Children With Cancer
A Multicenter 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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 550 (estimated)
- Sponsor
- Sydney Children's Hospitals Network · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Childhood Cancer
- Childhood Solid Tumor
- Childhood Brain Tumor
- Childhood Leukemia
- Refractory Cancer
- Relapsed Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-09-05
- Primary completion
- 2028-08-01
- Completion
- 2032-12-01
- First posted
- 2017-11-08
- Last updated
- 2024-04-23
Locations
8 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT03336931. Inclusion in this directory is not an endorsement.