Clinical trial · Observational
Understanding the Late Effects of Surviving a Pediatric Brain Tumor
Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
NCT03208387CI-TRIAL-00116724active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Pediatric Brain Tumor | Childhood Brain Neoplasm | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Beery Test of Visual Motor Integration 6th edition | Behavioral | — | UNRESOLVED |
| California Verbal Learning Test (CVLT-C) | Behavioral | — | UNRESOLVED |
| Diffusion tensor imaging (DTI) | Diagnostic Test | — | UNRESOLVED |
| Grooved Pegboard | Behavioral | — | UNRESOLVED |
| MRI | Diagnostic Test | — | UNRESOLVED |
| PedsQL Multidimensional Fatigue Scale | Behavioral | — | UNRESOLVED |
| Resting state functional connectivity MRI (rs-fcMRI) | Diagnostic Test | — | UNRESOLVED |
| Wechsler Intelligence Scale for Children - 5th edition (WISC-V) | Behavioral |
Design
Arms and outcomes
Arms (3)
- label
- Children Medulloblastoma Survivors
- description
- Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
- interventionNames
- Diagnostic Test: Diffusion tensor imaging (DTI)
- Diagnostic Test: Resting state functional connectivity MRI (rs-fcMRI)
- Behavioral: Wechsler Intelligence Scale for Children - 5th edition (WISC-V)
- Behavioral: California Verbal Learning Test (CVLT-C)
- Behavioral: Beery Test of Visual Motor Integration 6th edition
- Behavioral: Grooved Pegboard
- Behavioral: PedsQL Multidimensional Fatigue Scale
- Diagnostic Test: MRI
- label
- Children Astrocytoma Survivors
- description
- Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
- interventionNames
- Diagnostic Test: Diffusion tensor imaging (DTI)
- Diagnostic Test: Resting state functional connectivity MRI (rs-fcMRI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: Children Treated for Posterior Fossa Tumors: * As per medical record or clinical report, successfully completed all medical treatment for either an M0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease. * For medulloblastoma survivors only: Previously treated with gross total resection (GTR), craniospinal irradiation with conformal posterior fossa boost radiotherapy (CSI + Boost) and chemotherapy * For low grade astrocytoma survivors only: Previously treated with gross total resection ONLY (no chemotherapy or radiotherapy). * As per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor. * Subject is between the ages of 6 through 16 years at time of consent. * As per medical record or parent report, subject is able to tolerate an MRI without sedation. Healthy Control Participants: * No major medical illness, as determined by medical interview by study physician. * As per parent report, subject is between the ages of 6 through 16 years at time of consent. * As per parent report, subject is able to tolerate an MRI without sedation. Exclusion Criteria: All Participants: * Full Scale IQ as documented to be below a standard score of \<70 based upon the study IQ assessment completed after consent. * As per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year. * MRI contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures. * As per self or parent report or medical record, currently taking medications that have CNS effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma). * As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.
References
Publications (0)
Data not yet available
No reference posted for this study.