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Monitor immune microenvironment and systemic immune effects in pediatric oncology

Monitor immune microenvironment and systemic immune effects in pediatric oncology - Mimic study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52105
Enrollment
300
Registered
2021-04-01
Start date
2021-07-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumors cancer of blood cells tumors of the central nervous system

Interventions

None listed

Sponsors

Prinses Máxima Centrum voor Kinderoncologie
Lead Sponsor

Eligibility

Age
No minimum to 64 Years

Inclusion criteria

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 including craniopharyngiomas - MRI representing an image of a brain tumor, not resembling a germcell tumor - 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 - Newly diagnosed AML or relapse of AML - Written (parental) informed consent

Exclusion criteria

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) 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 (APL)

Design outcomes

Primary

MeasureTime frame
Brain tumors: To characterize and quantify changes in immune parameters during disease within patients with a CNS malignancy AML: To characterize and quantify changes in immune parameters during disease within patients with AML.

Secondary

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

Countries

Netherlands

Contacts

Public ContactJ. Lugt

Prinses Máxima Centrum voor Kinderoncologie

trialmanagement@prinsesmaximacentrum.nl0889729504

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)