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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00772200




Registration number
NCT00772200
Ethics application status
Date submitted
14/10/2008
Date registered
15/10/2008
Date last updated
8/04/2024

Titles & IDs
Public title
Neuropsychological and Behavioral Testing in Younger Patients With Cancer
Scientific title
Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
Secondary ID [1] 0 0
NCI-2009-00383
Secondary ID [2] 0 0
ALTE07C1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Malignant Neoplasm 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Cognitive Assessment
Other interventions - Quality-of-Life Assessment

Observational (neuropsychological and behavioral tests) - Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.


Treatment: Surgery: Cognitive Assessment
Complete COG Standard Neuropsychological and Behavioral Battery

Other interventions: Quality-of-Life Assessment
Ancillary studies
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compliance rate for completion of neuropsychological and behavioral battery
Timepoint [1] 0 0
Up to 72 months post-diagnosis

Eligibility
Key inclusion criteria
- The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic
study that aims to examine neuropsychological, social, emotional, and/or behavioral
functioning

- The patient must have receptive and expressive language skills in English, French, or
Spanish; if a patient meets these criteria but the parent/guardian speaks a language
other than English, French, or Spanish, the patient may still be enrolled and tested,
and the parent-report measures should be omitted

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Minimum age
1 Month
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with a history of moderate to profound intellectual disability (i.e.
intelligence quotient [IQ] =< 55) are not eligible for enrollment; PLEASE NOTE:
Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a
specific learning disability (e.g., dyslexia) are eligible for this study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [7] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [8] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [9] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6008 - Perth
Recruitment postcode(s) [9] 0 0
6009 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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California
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Connecticut
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Delaware
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Saskatchewan
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Auckland
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Christchurch
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Puerto Rico
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San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research trial studies neuropsychological (learning, remembering or thinking) and
behavioral outcomes in children and adolescents with cancer by collecting information over
time from a series of tests.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00772200
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leanne M Embry
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00772200