The aim is to characterize the immune infiltrate in the tumor microenvironment and to study the influence of the tumor on immune parameters in different compartments e.g. blood, bone marrow, CSF and faeces. In addition, a broad spectrum of immune…
ID
Source
Brief title
Health condition
Pediatric brain tumors
Sponsors and support
Intervention
Outcome measures
Primary outcome
Descriptive characterisation of lymphoid and myeloid subsets and activation status in different compartment, e.g. tumor microenvironment, blood, bone marrow, and CSF at different timepoints
Secondary outcome
Descriptive characterisation of lymphoid and myeloid subsets and activation status in different compartment, e.g. tumor microenvironment, blood, bone marrow, and CSF before after and during treatment Multivariate regression analysis of lymphoid and myeloid subsets and activation status in the different compartments in relation to overall survival and event free survival (event = relapse or death of any cause) response to therapy
Background summary
Cellular therapy and immune modifying interventions, e.g. checkpoint inhibition and antibody or CAR T-cell therapy show promising results in adult and pediatric tumors with a previously dismal prognosis. Whereas cellular therapy has been demonstrated to be effective in pediatric acute lymphoblastic leukemia, the efficacy of immunotherapy in neuro oncology needs to be further exploited. A thorough understanding of the tumor microenvironment and its influence on the immune system is the first step in the translation of preclinical immuno-oncology research into clinical trials.
Study objective
The aim is to characterize the immune infiltrate in the tumor microenvironment and to study the influence of the tumor on immune parameters in different compartments e.g. blood, bone marrow, CSF and faeces. In addition, a broad spectrum of immune parameters will be followed during treatment in different body compartments to describe the influence of therapy (surgery, radiotherapy and chemotherapy). At last, target finding will be incorporated in this project as an exploratory endpoint.
Study design
- Screening baseline - Resection or biopsy = day 0 - Day 14 +/-7 days - 3 months +/- 4 weeks - 6 months +/- 6 weeks - 12 months +/- 8 weeks = end of monitoring - Relapse
Raoull Hoogendijk
+31647959515
r.hoogendijk@prinsesmaximacentrum.nl
Raoull Hoogendijk
+31647959515
r.hoogendijk@prinsesmaximacentrum.nl
Inclusion criteria
- Age 0 – 18 years at inclusion - Newly diagnosed brain tumor or relapse of a brain tumor - MRI representing an image of a high grade brain tumor (high grade glioma, ependymoma, ATRT, medulloblastoma, or otherwise high grade) OR CNS tumor where based on MRI images the judgement of high grade versus low grade can’t be made. NB in case MRI imaging prior to biopsy and/or resection is not feasible, the patient can be included based on CT imaging and clinical assessment - Clinical indication for tumor biopsy/resection - Written (parental) informed consent
Exclusion criteria
- Suspected germ cell tumor on radiology or based on tumor markers (αFP, βHCG) - Suspected craniopharyngioma on radiology - Clear characteristics of low grade tumor
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8967 |
| CCMO | NL75515.041.21 |
| OMON | NL-OMON52105 |