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Comparison of neurocognitive outcome in two standard regimen for treatment of low-risk medulloblastoma (COGNITO-MB)
EU CTIS ID: 2024-517133-40-00
What this study is testing
To compare neurocognitive outcomes 2.5 years after diagnosis between patients with newly diagnosed, non-metastatic, SHH-activated, TP53-wt, non-MYC amplified MB randomized to the interventional arms A (“Head Start” 4) and B (HITSKK)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age at diagnosis < 5 years
- Patients with institutional suspicion or diagnosis of SHH-activated MB
- Patient and family in social circumstances that will allow neuropsychological follow-up
- Ability of parents/legal representatives to understand the patient information and to personal-ly sign and date the informed consent to participate in screening procedures
- Patient and the parents/legal representatives are able and willing to participate in the entire study (if patient is eligible)
You likely can't join if
- Patient previously treated for a brain tumor or any type of malignant disease
- Patients, in whom compliance with toxicity management guidelines and study procedures cannot be assured
- History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of an investigational medicinal product
- Patients/parents who do not wish to abstain from treatment with live vaccines during study participation
- Patients with a language barrier too extensive to complete neuropsychological tests based on the investigator’s judgment
- Patients with severe premorbid developmental delay (based on the investigator’s judgment), which will not allow WPPSI-IV assessment after 2.5 years
See the full eligibility criteria
- Age at diagnosis < 5 years
- Patients with institutional suspicion or diagnosis of SHH-activated MB
- Patient and family in social circumstances that will allow neuropsychological follow-up
- Ability of parents/legal representatives to understand the patient information and to personal-ly sign and date the informed consent to participate in screening procedures
- Patient and the parents/legal representatives are able and willing to participate in the entire study (if patient is eligible)
- Patient previously treated for a brain tumor or any type of malignant disease
- Patients, in whom compliance with toxicity management guidelines and study procedures cannot be assured
- History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of an investigational medicinal product
- Patients/parents who do not wish to abstain from treatment with live vaccines during study participation
- Patients with a language barrier too extensive to complete neuropsychological tests based on the investigator’s judgment
- Patients with severe premorbid developmental delay (based on the investigator’s judgment), which will not allow WPPSI-IV assessment after 2.5 years
- Patients that cannot undergo MRI
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.