Collecting and Storing Information From Patients With Cancer or Other Chronic Disease Who Have Undergone Neurobehavioral Assessments on Another Clinical Trial - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00459199

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.

Condition	Intervention
Brain and Central Nervous System Tumors Cognitive/Functional Effects Leukemia Long-term Effects Secondary to Cancer Therapy in Adults Long-term Effects Secondary to Cancer Therapy in Children Lymphoma Metastatic Cancer Neurofibromatosis Type 1 Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Other: physiologic testing Procedure: cognitive assessment Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Observational
Official Title:	Analysis of Stored Data Collected From Individuals Administered Neurobehavioral Assessments on IRB-Approved Protocols

Resource links provided by NLM:

Genetics Home Reference related topics: neurofibromatosis type 1 neurofibromatosis type 2 Help Me Understand Genetics

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Coping with Chronic Illness Leukemia Lymphoma Neurofibromatosis

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Neurobehavioral function

Secondary Outcome Measures:

Relationship between neurobehavioral test scores, medical variables, environmental factors, and demographic characteristics
Comparison of neurobehavioral measures between different subgroups of patients with varying levels of clinical, immunological, and virologic status
Changes in psychometric test scores over time

Estimated Enrollment:	300
Study Start Date:	January 2007

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459199

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Pam Wolters, PhD

National Cancer Institute (NCI)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00459199 History of Changes
Other Study ID Numbers:	070110, CDR0000538241, NCI-07-C-0110
Study First Received:	April 9, 2007
Last Updated:	September 29, 2011
Health Authority:	Unspecified

Keywords provided by National Institutes of Health Clinical Center (CC):

psychosocial effects of cancer and its treatment
cognitive/functional effects
long-term effects secondary to cancer therapy in adults
long-term effects secondary to cancer therapy in children
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
neurofibromatosis type 1
adult astrocytic tumors
adult brain stem glioma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult craniopharyngioma
adult embryonal tumor
adult ependymal tumors
adult meningeal tumor

adult oligodendroglial tumors
adult pineal parenchymal tumor
tumors metastatic to brain
recurrent adult brain tumor
adult mixed glioma
childhood mixed glioma
childhood brain stem glioma
childhood central nervous system germ cell tumor
childhood cerebellar astrocytoma
childhood cerebral astrocytoma/malignant glioma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood ependymoma
childhood medulloblastoma
childhood oligodendroglioma

Additional relevant MeSH terms:

Leukemia
Lymphoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Neurofibromatosis 1
Osteitis Fibrosa Cystica
Neurofibromatoses
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine

ClinicalTrials.gov processed this record on February 09, 2012