Clinical trial NCT03208387: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
Official title: Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Tumor
Pediatric Brain Tumor
Pediatric Cancer
Keywords: 17-338
Cognitive function
Behavioral function
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: University of Washington
name: University of Texas
name: Rutgers University
First posted: 2017-07-05
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited at MSK and three participating sites (Columbia University, University of Washington and University of Texas Southwestern).

Brief summary: The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibilty which is the number of eligible survivors consented per month
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Stephen Sands, PsyD
role: PRINCIPAL_INVESTIGATOR
References: