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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Cancer
- Sponsor
- Sydney Children's Hospitals Network
- Enrollment
- 550
- Locations
- 8
- Primary Endpoint
- Personalized medicine recommendation
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Dr David Ziegler
Professor
Sydney Children's Hospitals Network
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Personalized medicine recommendation
Time Frame: 5 years
Proportion of patients for whom personalized medicine recommendation can be made using a comprehensive diagnostic platform within a clinically relevant timeframe
Secondary Outcomes
- Patients receiving the recommended personalized therapy(5 years)
- Identification of potential treatment by in vitro or in vivo drug screening(5 years)
- Tumor samples with actionable molecular alterations(5 years)
- Successfully conducted in vitro high throughput drug screening and in vivo drug sensitivity testing(5 years)
- Reporting turnaround time(5 years)
- Barriers or reasons for patients not receiving the recommended personalized therapy(5 years)