CClinicalTrials.gg
CompletedNCT00693914Updated Apr 25, 2017

Working Memory Performance Among Childhood Brain Tumor Survivors

An observational study in Brain Tumors, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.

Sponsored by St. Jude Children's Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
130
Ages
8 Years to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Brain Tumors

Browse trials for

Keywords

  • Brain Tumor
  • Cognitive Late Effects
  • Radiation Therapy
  • Working Memory
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 130 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
130 participants (actual)

Groups and cohorts

  • 1: Brain Tumor Survivors (n=50)

    Behavioral: Series of tests/questionnaires

  • 2: Healthy Sibling Controls (n=40)

    Behavioral: Series of tests/questionnaires

  • Solid Tumor Survivors (n=40)

    Behavioral: Series of tests/questionnaires

Interventions

  • BehavioralSeries of tests/questionnaires

    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 Search: Verbal

06

What researchers measure

Primary outcomes

  1. Performance on experimental working memory measures (computerized self-ordered pointing tasks)

    Time frame: Collected during one time cross-sectional assessment.

Secondary outcomes

  1. 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.

07

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00693914
Lead sponsor
St. Jude Children's Research Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 9, 2008
Start date
Apr 2007
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Apr 25, 2017

Study contacts

Heather M Conklin, Ph.D.
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion