Protocol Number: 07-C-0110

Title:

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

Number:

07-C-0110

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility 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 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.

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.

Special Instructions:

Currently Not Provided

Keywords:

Cognitive

Behavior

Quality of Life

Psychological

Central Nervous System

Recruitment Keyword(s):

Behavior

Quality of Life

Condition(s):

HIV Infections

Central Nervous System Neoplasms

Neurofibromatosis 1

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Cooper ER, Hanson C, Diaz C, Mendez H, Abboud R, Nugent R, Pitt J, Rich K, Rodriguez EM, Smeriglio V. Encephalopathy and progression of human immunodeficiency virus disease in a cohort of children with perinatally acquired human immunodeficiency virus infection. Women and Infants Transmission Study Group. J Pediatr. 1998 May;132(5):808-12.

Brouwers P, DeCarli C, Civitello L, Moss H, Wolters P, Pizzo P. Correlation between computed tomographic brain scan abnormalities and neuropsychological function in children with symptomatic human immunodeficiency virus disease. Arch Neurol. 1995 Jan;52(1):39-44.

Pearson DA, McGrath NM, Nozyce M, Nichols SL, Raskino C, Brouwers P, Lifschitz MC, Baker CJ, Englund JA. Predicting HIV disease progression in children using measures of neuropsychological and neurological functioning. Pediatric AIDS clinical trials 152 study team. Pediatrics. 2000 Dec;106(6):E76.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/13/2009