PRecISion Medicine for Children With Cancer (PRISM)

Sydney Children's Hospitals Network

Status: Active, not recruiting

Conditions: Childhood Leukemia; Relapsed Cancer; Childhood Solid Tumor; Refractory Cancer; Childhood Cancer; Childhood Brain Tumor

Treatments: Diagnostic Test: Molecular profiling and drug testing

Study type: Observational

Funder types: Other

Identifiers

NCT03336931

PRISM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria (all must be met)

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

Trial design

550 participants in 1 patient group

High-risk childhood cancers

Description:

Expected survival \< 30%

Treatment:

Diagnostic Test: Molecular profiling and drug testing