Brain Tumor Clinical Trial
Official title:
Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
NCT number | NCT03208387 |
Other study ID # | 17-338 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 28, 2017 |
Est. completion date | June 2024 |
Verified date | July 2023 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
Status | Active, not recruiting |
Enrollment | 42 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Years to 16 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Columbia University | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Columbia University, Rutgers University, University of Texas, University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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