Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Memphis, Tennessee 38105


Purpose:

Children treated with radiation therapy for brain tumors are at risk for cognitive problems. These problems have typically been demonstrated on global cognitive measures including measures of intellectual functioning (IQ). Identification of specific areas of impairment can assist in isolating vulnerable brain areas and developing targeted interventions. In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling controls using measures of working memory (online maintenance and manipulation of information) in order to identify a specific cognitive process that may underlie the observed decline in IQ. We are also exploring relationships among working memory performance with IQ, clinical characteristics and a specific genetic factor of interest.


Study summary:

This is a cross-sectional controlled study of brain tumor survivors treated at St. Jude with conformal radiation therapy. Brain tumor survivors (n= 50, solid tumor survivors (n=40), and healthy sibling controls (n= 40) are evaluated once only with laboratory measures of cognitive skills (working memory, episodic memory and estimated IQ) and parental questionnaires (executive and adaptive functions). We also use buccal (cheek) swabs to gather samples for DNA extraction. We hypothesize: brain tumor survivors will perform significantly worse than solid tumor and healthy controls on measures of working memory, working memory will correlate significantly with IQ, working memory will be associated with parent report of executive functions and a specified genotype related to dopamine metabolism will be associated with working memory impairment.


Criteria:

Inclusion Criteria: Brain Tumor Patients - Treated for a primary central nervous system (CNS) tumor with conformal radiation therapy and enrolled on the institutional protocol RT-1 - Initiated radiation therapy at least 2 years prior to enrollment with no evidence of recurrent disease - Age 8-18 years inclusive at the time of enrollment, with sampling to obtain a broad cross-section of participants in terms of age, tumor location and time since RT initiation - English as the primary language - Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines Solid Tumor Patient Controls - Treated for a solid tumor (i.e., Ewing's sarcoma, osteosarcoma, soft tissue/rhabdomyosarcoma, neuroblastoma or Wilms tumor) at St. Jude without CNS directed therapy - Diagnosed at least 2 years prior to enrollment - Age 8-18 inclusive at the time of enrollment, with age, gender and race sampling to broadly match the brain tumor group - English as the primary language - Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines Sibling Controls - Healthy sibling controls- siblings of St. Jude patients treated for a brain tumor (not necessarily on RT-1) - Age 8-18 inclusive, with age and gender sampling to broadly match the patient group - English as a primary language - Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines Exclusion Criteria: Brain Tumor Patients - Significant impairment in global intellectual functioning (operationalized as an estimated IQ less than 70 as indicated by most recent RT-1 testing) - History of documented CNS injury or disease predating cancer diagnosis - History of documented Attention Deficit Hyperactivity Disorder (ADHD) predating cancer diagnosis by at least one year (must have been diagnosed by a physician with medication prescribed) - Treatment with psychostimulant or psychotropic medication within two weeks of study enrollment - Sensory or motor impairment that would preclude valid cognitive testing Solid Tumor and Sibling Controls - Significant impairment in global intellectual functioning (operationalized as a history of special education in a self-contained classroom) - History of documented CNS injury or disease - History of documented Attention Deficit Hyperactivity Disorder (ADHD) (must have been diagnosed by a physician with medication prescribed) - Treatment with psychostimulant or psychotropic medication within two weeks of study enrollment - Sensory or motor impairment that would preclude valid cognitive testing


Study is Available At:


Original ID:

EXFXN1


NCT ID:

NCT00693914


Secondary ID:

R21CA131616


Study Acronym:


Brief Title:

Working Memory Performance Among Childhood Brain Tumor Survivors


Official Title:

Working Memory Performance Among Childhood Brain Tumor Survivors Treated With Conformal Radiation Therapy: A Pilot Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

8 Years


Maximum Age:

18 Years


Quick Facts

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

Study Source:

St. Jude Children's Research Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

130


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Heather M Conklin, Ph.D.
Principal Investigator
St. Jude Children's Research Hospital

Study Dates

Start Date:April 2007
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:October 2011
Last Changed Date:October 3, 2011
First Received Date:June 5, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Abbreviated IQ (WASI), episodic memory measures (computerized word and face recognition tasks) and parent questionnaires of executive (BRIEF) and adaptive (ABAS-II) functioning.
Time Frame:Collected during one time cross-sectional assessment.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Performance on experimental working memory measures (computerized self-ordered pointing tasks)
Time Frame:Collected during one time cross-sectional assessment.
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Series of tests/questionnaires
Description:Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order S
Arm Name:1: Brain Tumor Survivors (n=50)

Study Arms

Study Arm Type:Other
Arm Name:1: Brain Tumor Survivors (n=50)
Study Arm Type:Other
Arm Name:2: Healthy Sibling Controls (n=40)
Study Arm Type:Other
Arm Name:Solid Tumor Survivors (n=40)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Jude Children's Research Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Study Population: Both the patient group and sibling group will be accrued using a broad stratification process for gender (Male, Female) and age (8-12 years of age, 13-18 years of age).
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.