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
1 other identifier
observational
42
1 country
4
Brief Summary
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2017
CompletedFirst Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
September 12, 2025
September 1, 2025
8.9 years
June 29, 2017
September 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibilty which is the number of eligible survivors consented per month
The study is a pilot study to collect information on feasibility broadly defined. The feasibility indicators are primarily descriptive variables, including a careful monitoring of accrual rate (how many eligible survivors consented per month).
2 years
Study Arms (3)
Children Medulloblastoma Survivors
Participants previously treated for M0 non-disseminated medulloblastoma with cranio-spinal irradiation plus a boost to the posterior fossa
Children Astrocytoma Survivors
Participants previously treated for a low grade cerebellar astrocytoma, with surgery only and neither chemotherapy nor cranial irradiation.
Age-Matched Healthy Children Controls
Interventions
DTI quantifies the degree to which water diffuses in different directions through a given brain region. The use of DTI as an in vivo index of the integrity of white matter has been applied to many disease states using several proprietary and open-source software programs (e.g. FSL 5.0). DTI tractography, employed via toolboxes such as Probtrackx within the FSL 5.0, allows the identification of white matter tracts connecting cortical and subcortical regions of interest. Furthermore, structural connectivity as measured with DTI does not duplicate functional connectivity as measure with rs-fcMRI, but rather provides complimentary perspectives.
rs-fcMRI is a relatively new neuroimaging technique that has been applied to studying multiple clinical populations including ADHD, schizophrenia, major depressive disorder, and other neurological disorders. The approach exploits measurement of changes in brain blood oxygenation (BOLD) as is employed in task based functional MRI (measuring changes in focal cortical vascular oxygenation when engaged in a defined task, e.g. motor movement). Neuroimaging data will be collected as soon as possible (can be the same day), for up to 6 weeks.
Will gather IQ data and is the gold standard for IQ assessment for those between the ages of 6:0 and 16:11 years.
Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
Measure designed to assess visual-motor functioning of subjects between the ages of 2-99 years old by copying designs using paper and pencil.
This is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board.
Designed to measure fatigue in pediatric patients (ages 5-17 years) and is comprised of the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items).
Images will be acquired on a 3.0 Tesla MRI scanner at each of the four study sites. At MSK, resting state fMRI data will be obtained using a 3T GE scanner with an 8-channel head coil (Discovery 750w DV25)
Eligibility Criteria
Participants will be recruited at MSK and three participating sites (Columbia University, University of Washington and University of Texas Southwestern).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Columbia Universitycollaborator
- University of Washingtoncollaborator
- University of Texascollaborator
- Rutgers Universitycollaborator
Study Sites (4)
Columbia University
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Sands, PsyD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 5, 2017
Study Start
June 28, 2017
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
September 12, 2025
Record last verified: 2025-09