Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Month and Over
Gender	All

More Inclusion & Exclusion Criteria

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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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01445314
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pamela L Wolters, Ph.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	HIV, Brain Tumors, Neurofibromatosis Type 1
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: 1/Patients

Infants, children, adolescents, and adults who have taken neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.

Interventions

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Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

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