View Clinical Trial (Medical Research Study)
Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Brain and Central Nervous System Tumors - Cognitive/Functional Effects - Leukemia - Long-term Effects Secondary to Cancer Therapy in Adults - Long-term Effects Secondary to Cancer Therapy in Children - Lymphoma - Metastatic Cancer - Neurofibromatosis Type |
| Purpose: |
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RATIONALE: Learning about neurobehavioral function and quality of life over time in patients
with cancer or other chronic disease may help doctors learn about the long-term effects of
treatment and plan the best treatment.
PURPOSE: This clinical trial is collecting and storing information over time from patients
with cancer or other chronic disease who have undergone neurobehavioral assessments on
another clinical trial.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine the neurobehavioral function of patients with chronic illness by analyzing
stored data collected from IRB-approved protocols comprising retrospective data
collected on protocols that are now closed and prospective data from current and future
protocols.
Secondary
- Determine the relationship between neurobehavioral functioning and medical,
neuroimaging, neurologic, and psychiatric variables in these patients.
- Determine the association of neurobehavioral functioning and medication adherence, life
events, and family functioning in these patients.
- Compare neurobehavioral measures between different subgroups within an illness group.
- Determine the effects of treatment (e.g., antiretroviral therapy, radiation therapy) on
neurobehavioral functioning over time in these patients.
- Compare the responses of patients and caregivers on behavioral, adherence, and quality
of life questionnaires.
- Compare various aspects of neurobehavioral functioning between patients with different
chronic medical conditions.
- Validate novel assessment tools developed to better measure specific domains of
functioning, such as quality of life and neurologic function in children with chronic
illnesses with possible CNS involvement.
OUTLINE: This is a longitudinal, retrospective, and prospective study.
Retrospective data previously collected from patients enrolled on IRB-approved protocols is
identified from the secure NCI/Medical Illness Counseling Center (MICC) neuropsychological
database.
Prospective data is collected from patients as specified in current or future IRB-approved
protocols and entered in the secure NCI/MICC neuropsychological database within 1 month of
assessment.
Retrospective and prospective data collected from multisite IRB-approved protocols, that
have a CCR investigator and the neurobehavioral data managed by NCI, may be included in
analyses when appropriate.
Various cross-sectional and/or longitudinal analyses are conducted on the selected data in
the NCI/MICC neuropsychological database when appropriate.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Any of the following diagnoses are allowed:
- HIV positivity
- Cancer (especially brain tumors and leukemia)
- Neurofibromatosis type 1
- Data obtained from infants, children, adolescents, and adults who underwent
neurobehavioral assessments as part of a past, current, or future IRB-approved
protocol
- No CNS condition (i.e., Down syndrome, severe intraventricular hemorrhage) not
related to primary medical diagnosis (i.e., HIV, cancer) that may affect
neurobehavioral functioning, missing values on a particular test being studied, or
invalid data as determined by the investigator
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
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| NCT ID: |
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NCT00459199 |
| Primary Contact: |
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Study Chair
Pam Wolters, PhD
National Cancer Institute (NCI)
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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