Bethesda, Maryland 20892

  • Neurofibromatosis Type

Purpose:

RATIONALE: Learning about neurobehavioral function and quality of life over time in patients with cancer or other chronic disease may help doctors learn about the long-term effects of treatment and plan the best treatment. PURPOSE: This clinical trial is collecting and storing information over time from patients with cancer or other chronic disease who have undergone neurobehavioral assessments on another clinical trial.


Study summary:

OBJECTIVES: Primary - Determine the neurobehavioral function of patients with chronic illness by analyzing stored data collected from IRB-approved protocols comprising retrospective data collected on protocols that are now closed and prospective data from current and future protocols. Secondary - Determine the relationship between neurobehavioral functioning and medical, neuroimaging, neurologic, and psychiatric variables in these patients. - Determine the association of neurobehavioral functioning and medication adherence, life events, and family functioning in these patients. - Compare neurobehavioral measures between different subgroups within an illness group. - Determine the effects of treatment (e.g., antiretroviral therapy, radiation therapy) on neurobehavioral functioning over time in these patients. - Compare the responses of patients and caregivers on behavioral, adherence, and quality of life questionnaires. - Compare various aspects of neurobehavioral functioning between patients with different chronic medical conditions. - Validate novel assessment tools developed to better measure specific domains of functioning, such as quality of life and neurologic function in children with chronic illnesses with possible CNS involvement. OUTLINE: This is a longitudinal, retrospective, and prospective study. Retrospective data previously collected from patients enrolled on IRB-approved protocols is identified from the secure NCI/Medical Illness Counseling Center (MICC) neuropsychological database. Prospective data is collected from patients as specified in current or future IRB-approved protocols and entered in the secure NCI/MICC neuropsychological database within 1 month of assessment. Retrospective and prospective data collected from multisite IRB-approved protocols, that have a CCR investigator and the neurobehavioral data managed by NCI, may be included in analyses when appropriate. Various cross-sectional and/or longitudinal analyses are conducted on the selected data in the NCI/MICC neuropsychological database when appropriate. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Any of the following diagnoses are allowed: - HIV positivity - Cancer (especially brain tumors and leukemia) - Neurofibromatosis type 1 - Data obtained from infants, children, adolescents, and adults who underwent neurobehavioral assessments as part of a past, current, or future IRB-approved protocol - No CNS condition (i.e., Down syndrome, severe intraventricular hemorrhage) not related to primary medical diagnosis (i.e., HIV, cancer) that may affect neurobehavioral functioning, missing values on a particular test being studied, or invalid data as determined by the investigator PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - Not specified


Study is Available At:


Original ID:

070110, CDR0000538241


NCT ID:

NCT00459199


Secondary ID:

NCI-07-C-0110


Study Acronym:


Brief Title:

Collecting and Storing Information From Patients With Cancer or Other Chronic Disease Who Have Undergone Neurobehavioral Assessments on Another Clinic


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Pam Wolters, PhD
Study Chair
National Cancer Institute (NCI)

Study Dates

Start Date:January 2007
Verification Date:September 2011
Last Changed Date:September 29, 2011
First Received Date:April 9, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Neurobehavioral function
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Relationship between neurobehavioral test scores, medical variables, environmental factors, and demographic characteristics
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Comparison of neurobehavioral measures between different subgroups of patients with varying levels of clinical, immunological, and virologic status
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in psychometric test scores over time
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:physiologic testing
Intervention Type:Procedure
Name:cognitive assessment
Intervention Type:Procedure
Name:management of therapy complications
Intervention Type:Procedure
Name:psychosocial assessment and care
Intervention Type:Procedure
Name:quality-of-life assessment

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 08, 2023

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