Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors
1. This study will evaluate the association between changes in basic cognitive and
behavioral functioning by the end of chemotherapy treatment, and the later development
of higher order executive functions in pediatric acute lymphoblastic leukemia (ALL).
2. The association between acute treatment-related changes in brain integrity and
subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated.
3. The association between patterns of behavioral and executive dysfunction and brain
maturation in long-term survivors of pediatric ALL will be examined.
4. The association between genetic polymorphisms in key enzyme pathways and higher order
brain development in long-term survivors of pediatric ALL will be explored.
5. The associations between biologic and behavioral indices of fatigue/sleep and higher
order brain development in long-term survivors of pediatric ALL will be explored.
Survival rates for pediatric acute lymphoblastic leukemia (ALL) now exceed 80%. With this
growing population of long-term survivors comes recognition that a considerable proportion
experience one or more significant late effects. For children undergoing central nervous
system (CNS) treatment, common late effects include neurocognitive impairment and
neurobehavioral problems. Although these problems first manifest as subtle difficulties with
attention and processing speed, they can evolve into deficits in higher order brain
functions that significantly impact functional skills in a subset of long-term survivors.
There currently is no method to accurately identify patients at greatest risk for these
long-term behavioral and neurocognitive problems. Through this proposal, this study plans to
utilize existing data collected during acute treatment to identify predictors of long-term
neurocognitive and brain maturation outcomes. The study also proposes to collect data on
attention-deficit/hyperactivity disorder (ADHD) and associated comorbidities, higher order
executive functions, and structural and functional brain imaging in survivors who are at
least 8 years of age and greater than 5 years from diagnosis.
All patients will undergo a single neurocognitive evaluation focused on assessment of higher
order executive functions. Patients will be evaluated during their regularly scheduled
annual follow-up visit, when health-related monitoring will also occur. Parents of
participants will be asked to complete questionnaires designed to assess the family
environment and the impact of cancer diagnosis on family functioning and parent stress.
Brain Imaging: To better demonstrate untoward treatment effects upon cortical brain
development, quantitative MR imaging of myelin integrity using diffusion tensor imaging
(DTI) and cortical thickness assessment using high resolution volumetric imaging will be
utilized. All patients will also be evaluated using functional MRI (fMRI) procedures during
resting state and participation in attention and working memory tasks. fMRI and DTI data
will be de-identified then analyzed at MD Anderson Cancer Center in Houston, Texas.
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Observational Model: Case-Only, Time Perspective: Prospective
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