Clinical trial · Observational
Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments
Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| HIV | — | UNRESOLVED | — |
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1/Patients
- description
- Infants, children, adolescents, and adults who have taken neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.
Primary outcomes (1)
- measure
- Functional
- timeFrame
- 1 Year
- description
- describe neurobehavioural functioning based on stored data
Secondary outcomes (7)
- measure
- Validation
- timeFrame
- 5 years
- description
- validate novel assessment tools
- measure
- Relationship
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDHofman 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. PMID 8151460
- BACKGROUNDButler 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. PMID 7989937
- BACKGROUNDTardieu 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. PMID 12014189