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Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols


N/A
N/A
N/A
Open (Enrolling)
Both
HIV Infections, Central Nervous System Neoplasms, Neurofibromatosis 1

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Trial Information

Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols


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 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.

Objectives:

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.

Inclusion Criteria


- INCLUSION CRITERIA:

1. Data obtained from infants, children, adolescents, and adults administered
neurobehavioral assessments as part of a past, current, or future IRB-approved
protocol.

2. 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.

3. 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Pamela L Wolters, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

070110

NCT ID:

NCT01445314

Start Date:

February 2007

Completion Date:

Related Keywords:

  • HIV Infections
  • Central Nervous System Neoplasms
  • Neurofibromatosis 1
  • Cognitive
  • Behavior
  • Quality of Life
  • Psychological
  • Central Nervous System
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Neoplasms
  • Nervous System Neoplasms
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Central Nervous System Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892