Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03336931

PRecISion Medicine for Children With Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Childhood Cancer Childhood Brain Tumor Childhood Leukemia Childhood Solid Tumor Disease Attributes Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Refractory Cancer Relapsed Cancer

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John Hunter Children's Hospital, Newcastle, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all must be met)

  • Age ≤ 21 years
  • Histologic diagnosis of high-risk malignancy defined as expected overall survival < 30% OR where standard therapy would result in unacceptable and severe morbidity
  • Appropriate tissue samples are available for analysis
  • Life expectancy > 6 weeks
  • Written informed consent

Treatment and study plan

Molecular profiling and drug testing

Diagnostic Test
  • 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

  • Multi-disciplinary Tumour Board case discussion
  • Recommendation of personalised therapy

Primary outcomes

  1. 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

  1. Tumor samples with actionable molecular alterations

    Time frame: 5 years

    Proportion of tumor samples found to have actionable molecular alterations

  2. Successfully conducted in vitro high throughput drug screening and in vivo drug sensitivity testing

    Time frame: 5 years

    Proportion of tumours where in vitro high throughput drug screening and in vivo drug sensitivity testing can be successfully performed

  3. Identification of potential treatment by in vitro or in vivo drug screening

    Time frame: 5 years

    Proportion of tumors for which a potential treatment option is identified by in vitro or in vivo drug screening

  4. Reporting turnaround time

    Time frame: 5 years

    Number of weeks from enrollment to issuing a report to the treating clinician

  5. Patients receiving the recommended personalized therapy

    Time frame: 5 years

    Proportion of patients who subsequently receive the recommended personalized therapy

  6. Barriers or reasons for patients not receiving the recommended personalized therapy

    Time frame: 5 years

    Description of the barriers or reasons for patients not receiving the recommended personalized therapy

Other outcomes

  1. Impact of personalized therapy on progression-free survival

    Time frame: Up to 5 years

    Time interval from enrollment until disease progression or death for patients who have received personalized therapy versus those who have not

  2. Impact of personalized therapy on overall survival

    Time frame: Up to 5 years

    Time interval from enrollment until death for patients who have received personalized therapy versus those who have not

Sponsors and collaborators

Lead sponsor

Sydney Children's Hospitals Network

Other

Collaborators

  • Australian & New Zealand Children's Haematology/Oncology Group
  • Children's Cancer Institute Australia
  • Garvan Institute of Medical Research
  • German Cancer Research Center

Registry information

Official study title

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

Acronym: PRISM

Important dates

Study start
2017
Primary completion
2028
Study completion
2032
First posted
Nov 8, 2017
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.