NCT01445314Completed
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 · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 598 (actual)
- First submitted
- 30 Sept 2011
- Start date
- 23 Mar 2007
- Primary completion date
- 8 Aug 2024
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- HIV, Childhood cancers
- NCT number
- NCT01445314
What you commit to
- Study type: Observational
- Participants enrolled: 598
- From 23 Mar 2007 to the primary completion date, 8 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Data obtained from infants, children, adolescents, and adults administered neurobehavioral assessments as part of a past, current, or future IRB-approved protocol.
- 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.
- Data obtained from healthy controls, which may be siblings of affected patients, administered neurobehavioral assessments on an IRB-approved protocol.
Age in the registry: 1 month to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.