relapse refractory, pediatric oncology, molecular profiling, actionable lesions recidief refractair, kinderoncologie, moleculaire profilering, behandelbare laesies Pediatric Relapsed/Refractory Malignancies
Conditions
Interventions
Sponsors
Prinses Máxima Center voor kinderoncologie
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: -relapsed/refractory pediatric cancer, which was established at initial diagnosis by standard diagnostic methods -no available standard treatment or study protocol -life-expectancy of at least 10 weeks -written informed consent according to local law and legislation -age <30 years
Exclusion criteria
Exclusion criteria: -biopsy considered unsafe -severe organ toxicity precluding undergoing any of the procedures mentioned in this protocol -any other condition that may hamper participation according to the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the number of patients with relapsed/refractory pediatric tumors for whom no standard protocol treatment is available, in whom actionable lesions are identified | — |
Secondary
| Measure | Time frame |
|---|---|
| • To determine the number of patients with relapsed/refractory pediatric tumors in the Netherlands each year for whom no standard protocol or treatment is available (per protocol population) • The percentage of patients who are able to undergo a diagnostic tumor biopsy (as standard of care) • The percentage of tumor biopsies associated with procedure-related complications • The percentage of cases in which tumor material was obtained of sufficient quality for molecular profiling • The percentage of cases in which one or more actionable lesions are identified • The percentage of cases in which a mutation in a cancer predisposition gene is identified • The percentage of cases in which the molecular tumor board is able to provide a treatment advice to the treating physician • The time frame between the date of the biopsy and the date of the treatment advice by the molecular tumor board • The percentage of patients treated according to the treatment recommendation • Major side-effects and disease responses observed in the patients treated • Survival parameters (overall and progression-free survival) in the entire cohort of patients with a follow-up duration of 1 year following enrolment. | — |
Contacts
Public ContactC.M. Zwaan
Dept. of Pediatric Oncology-Hematology Erasmus MC-Sophia Children's Hospital POB 2060
Outcome results
None listed