Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01445314
• Other study ID #: 070110
• Secondary ID: 07-C-0110
• Status: Enrolling by invitation
• Start date: March 23, 2007

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00459199

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 720
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Brain Tumors
• HIV
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional	describe neurobehavioural functioning based on stored data	1 Year
Secondary	Validation	validate novel assessment tools	5 years
Secondary	Relationship	relationship between neurobehavioral functioning & medical, neuroimaging, neurologic, and psychiatric variables	5 years
Secondary	Effects	effects of treatment on neurobehavioral functioning over time	5 years
Secondary	Comparison	compare neurobehavioral measures between different subgroups within	5 years
Secondary	Comparison	compare neurobehavioral functioning between different chronic medical conditions	5 years
Secondary	Association	association of neurobehavioral functioning with medication	5 years
Secondary	Adherence & QOL	compare the responses of the patient and caregiver on behavioral adherence & QOL	5 years

External Links

•   NIH Clinical Center Detailed Web Page