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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

07-C-0110

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 1 mo
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Keywords

Stored Data;
Neurobehavioral;
Natural History

Recruitment Keyword(s)

Behavior;
Quality of Life

Condition(s)

HIV;
Brain Tumors;
Neurofibromatosis Type 1

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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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.


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Citations:

Hofman KJ, Harris EL, Bryan RN, Denckla MB. Neurofibromatosis type 1: the cognitive phenotype. J Pediatr. 1994 Apr;124(4):S1-8.

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.

Tardieu M, Boutet A. HIV-1 and the central nervous system. Curr Top Microbiol Immunol. 2002;265:183-95.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Pamela L. Wolters, Ph.D.
National Cancer Institute (NCI)
NIHBC 82 - RA BLOCH INTERNATIONAL CANCER CENTER BG RM 105
9030 OLD GEORGETOWN RD
BETHESDA MD 20892
(240) 760-6035
woltersp@mail.nih.gov

Pamela L. Wolters, Ph.D.
National Cancer Institute (NCI)
NIHBC 82 - RA BLOCH INTERNATIONAL CANCER CENTER BG RM 105
9030 OLD GEORGETOWN RD
BETHESDA MD 20892
(240) 760-6035
woltersp@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01445314

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