Monitor immune microenvironment and systemic immune effects in pediatric oncology

Recruiting

• Conditions: Brain tumors; cancer of blood cells; tumors of the central nervous system; acute myeloid leukemia; 10024324; 10029211

• Registration Number: NL-OMON52105
• Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

For Brain tumor arm:
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Patients
- Age 0 - 25 years at inclusion
- Newly diagnosed brain tumor or relapse of a brain tumor
- MRI representing an image of a brain tumor, not resembling a germcell tumor
or a craniopharyngioma
- Clinical indication for tumor biopsy/resection
- Written (parental) informed consent

Healthy controls
- Sibling of a patient already participating in the MIMIC brain study
- Age 0 - 25 years at inclusion
- Written (parental) informed consent

For AML:
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Age 0 - 21 years at inclusion
Treatment at a Pediatric Cancer Center (Princess Maxima Center for Pediatric
Oncology)
Newly diagnosed AML, including relapse of AML that was not previously included
at diagnosis
Written (parental) informed consent

Exclusion Criteria

For Brain tumor arm:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Suspected germ cell tumor on radiology or based on tumor markers (aFP, βHCG)
- Suspected craniopharyngioma on radiology
- Not willing to consent

For AML arm:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- acute myeloid leukemia in children with Down syndrome
- acute promyelocytic leukemia
- not willing to consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Brain tumors: To characterize and quantify changes in immune parameters during<br /><br>disease within patients with a CNS malignancy<br /><br><br /><br>AML: To characterize and quantify changes in immune parameters during disease<br /><br>within patients with AML. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Brain tumors:<br /><br><br /><br>Secondary Objectives<br /><br>To evaluate the effect of therapy on the immune profiles<br /><br>To evaluate survival for different molecular- and immune profiles<br /><br><br /><br><br /><br>Explorative Objectives<br /><br>To determine tumor-specific cell surface proteins<br /><br>To characterize tumor infiltrating lymphocytes<br /><br>To determine faeces composition<br /><br>To correlate molecular characteristics with the immune profile for the<br /><br>different tumor entities<br /><br><br /><br>AML:<br /><br><br /><br>Exploratory objectives:<br /><br>To evaluate survival and treatment response for different molecular- and immune<br /><br>profiles<br /><br>To characterize the amenability of primary AML samples and immune cells to<br /><br>respond to immunotherapy in preclinical models</p><br>