- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01445314
Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments
Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols
Background:
- People with chronic illness often are at risk for developing neurobehavioral problems due to effects of the disease or associated treatments. These problems may include cognitive impairments involving problem-solving, remembering things, paying attention, and understanding and using language, or emotional functioning or quality of life.
- The National Cancer Institute Medical Illness Counseling Center Neuropsychology Group has collected data from neurobehavioral evaluations of infants, children, adolescents and adults with chronic illnesses enrolled in NIH protocols since 1987 and continues to collect data from patients enrolled in current protocols.
- The data from these evaluations, along with demographic and medical information are stored in an NIH computer database.
- Investigating the neurobehavioral functioning of patients with chronic illness is important for identifying and monitoring the effects of the disease and treatments over time, determining possible at-risk subgroups, evaluating response to therapy, and recommending educational and rehabilitative interventions.
Objectives:
-To learn about how certain illnesses or treatments may affect a person s cognitive abilities, emotional functioning and quality of life.
Eligibility:
- Patients currently enrolled in NIH studies who are having neuropsychological testing or completing quality-of-life questionnaires as part of that study.
- Data obtained from infants, children, adolescents, and adults administered neurobehavioral assessments as part of a past or future NIH protocol.
Design:
- This study does not involve any extra tests or questionnaires; it uses information collected from evaluations that subjects have already completed or will complete as part of other NIH studies.
- Information about participating patients that may help elucidate how cognitive abilities, emotional functioning, and quality of life are affected in people with chronic illness may be collected and stored.
Study Overview
Status
Conditions
Detailed Description
Background:
Individuals with chronic illness often are at risk for developing neurobehavioral impairments due to effects of the disease and/or associated treatments.
The National Cancer Institute (NCI) Neurobehavioral Group has been collecting neurobehavioral data obtained from the longitudinal psychometric testing of infants, children, adolescents, and adults with various chronic illnesses enrolled on IRB-approved protocols at the NIH since the 1980 s, many of which are now closed. In addition, we continue to collect neurobehavioral data obtained from assessments of individuals enrolled on current IRB-approved protocols.
The neurobehavioral test data from these evaluations, as well as demographic information, medical values, neurologic findings, and neuroimaging abnormalities, are stored in the neuropsychological database currently located on the secure NIH mainframe computer system.
Investigating the neurobehavioral functioning of children with chronic illness is important for identifying and monitoring the effects of the disease and treatments over time, determining possible at-risk subgroups, evaluating response to therapy, and recommending educational and rehabilitative interventions. In addition, the data may be used to compare various aspects of neurobehavioral functioning among different illness groups healthy controls, and validate novel methodologies to better assess selected domains of functioning, such as a pediatric quality of life (QOL) scale for children with chronic illnesses with CNS involvement.
Objective:
To describe the neurobehavioral functioning of individuals with chronic illness based on the analysis of stored data collected from IRB-approved protocols, consisting of retrospective data collected on protocols that are now closed and data collected prospectively on current and future protocols.
Eligibility:
Data obtained from infants, children, adolescents, and adults administered neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.
Design:
No data will be collected specifically for this protocol. Retrospective data previously collected from individuals receiving neurobehavioral assessments as part of past IRB-approved protocols or prospective data that already will be collected as specified in current or future IRB-approved protocols and stored in the secure NCI Neurobehavioral database will be used for data analysis as outlined in this protocol.
Cross-sectional or longitudinal data will be selected from the database for statistical analysis based on the objective being studied. Since different objectives may be studied using various types of data, a variety of statistical analyses will be conducted to examine the stored data depending on the objective being studied.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
- Data obtained from infants, children, adolescents, and adults administered neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.
- Informed consent for subjects greater than or equal to 18 years of age, a legal representative to provide permission for subjects greater than or equal to 18 years who cannot give informed consent, or one parent-legal guardian to provide permission for subjects less than 18 years of age who are administered neurobehavioral assessments after this protocol is approved.
- Data obtained from healthy controls, which may be siblings of affected patients, administered neurobehavioral assessments on an IRB-approved protocol.
EXCLUSION CRITERIA:
1. Data may be excluded from a particular analysis if a subject had a CNS condition (i.e., Down s syndrome, severe intraventricular hemorrhage) not related to their primary medical diagnosis (i.e., HIV, cancer) that may affect neurobehavioral functioning, missing values on a particular test being studied, or invalid data as judged by the PI or Chairperson.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
---|
1/Patients
Infants, children, adolescents, and adults who have taken neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional
Time Frame: 1 Year
|
describe neurobehavioural functioning based on stored data
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation
Time Frame: 5 years
|
validate novel assessment tools
|
5 years
|
Relationship
Time Frame: 5 years
|
relationship between neurobehavioral functioning & medical, neuroimaging, neurologic, and psychiatric variables
|
5 years
|
Effects
Time Frame: 5 years
|
effects of treatment on neurobehavioral functioning over time
|
5 years
|
Comparison
Time Frame: 5 years
|
compare neurobehavioral measures between different subgroups within
|
5 years
|
Comparison
Time Frame: 5 years
|
compare neurobehavioral functioning between different chronic medical conditions
|
5 years
|
Association
Time Frame: 5 years
|
association of neurobehavioral functioning with medication
|
5 years
|
Adherence & QOL
Time Frame: 5 years
|
compare the responses of the patient and caregiver on behavioral adherence & QOL
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pamela L Wolters, Ph.D., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Hofman KJ, Harris EL, Bryan RN, Denckla MB. Neurofibromatosis type 1: the cognitive phenotype. J Pediatr. 1994 Apr;124(4):S1-8. doi: 10.1016/s0022-3476(05)83163-4.
- Butler RW, Hill JM, Steinherz PG, Meyers PA, Finlay JL. Neuropsychologic effects of cranial irradiation, intrathecal methotrexate, and systemic methotrexate in childhood cancer. J Clin Oncol. 1994 Dec;12(12):2621-9. doi: 10.1200/JCO.1994.12.12.2621.
- Tardieu M, Boutet A. HIV-1 and the central nervous system. Curr Top Microbiol Immunol. 2002;265:183-95. doi: 10.1007/978-3-662-09525-6_9. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibroma
Other Study ID Numbers
- 070110
- 07-C-0110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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