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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00693914 |
Children treated with radiation therapy for brain tumors are at risk for cognitive problems. These problems have typically been demonstrated on global cognitive measures including measures of intellectual functioning (IQ). Identification of specific areas of impairment can assist in isolating vulnerable brain areas and developing targeted interventions.
In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling controls using measures of working memory (online maintenance and manipulation of information) in order to identify a specific cognitive process that may underlie the observed decline in IQ. We are also exploring relationships among working memory performance with IQ, clinical characteristics and a specific genetic factor of interest.
Condition | Intervention |
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Brain Tumors |
Behavioral: Series of tests/questionnaires |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Working Memory Performance Among Childhood Brain Tumor Survivors Treated With Conformal Radiation Therapy: A Pilot Study |
Estimated Enrollment: | 130 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1: Brain Tumor Survivors (n=50) |
Behavioral: Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievment Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
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2: Healthy Sibling Controls (n=40) |
Behavioral: Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievment Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
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Solid Tumor Survivors (n=40) |
Behavioral: Series of tests/questionnaires
Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievment Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
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This is a cross-sectional controlled study of brain tumor survivors treated at St. Jude with conformal radiation therapy. Brain tumor survivors (n= 50, solid tumor survivors (n=40), and healthy sibling controls (n= 40) are evaluated once only with laboratory measures of cognitive skills (working memory, episodic memory and estimated IQ) and parental questionnaires (executive and adaptive functions). We also use buccal (cheek) swabs to gather samples for DNA extraction. We hypothesize: brain tumor survivors will perform significantly worse than solid tumor and healthy controls on measures of working memory, working memory will correlate significantly with IQ, working memory will be associated with parent report of executive functions and a specified genotype related to dopamine metabolism will be associated with working memory impairment.
Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Both the patient group and sibling group will be accrued using a broad stratification process for gender (Male, Female) and age (8-12 years of age, 13-18 years of age).
Inclusion Criteria:
Brain Tumor Patients
Solid Tumor Patient Controls
Sibling Controls
Exclusion Criteria:
Brain Tumor Patients
Solid Tumor and Sibling Controls
Contact: Heather M Conklin, Ph.D. | 1-866-278-5833 | info@stjude.org |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Heather M Conklin, PH.D. 866-278-5833 info@stjude.org | |
Principal Investigator: Heather M Conklin, Ph.D. |
Principal Investigator: | Heather M Conklin, Ph.D. | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Heather M. Conklin, Ph.D. ) |
Study ID Numbers: | EXFXN1 |
Study First Received: | June 5, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00693914 |
Health Authority: | United States: Institutional Review Board |
Brain Tumor Cognitive Late Effects Radiation Therapy Working Memory |
Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases |