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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/NCT00003096




Registration number
NCT00003096
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
6/08/2014

Titles & IDs
Public title
Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
Scientific title
Molecular Biology of Pediatric Brain Tumors
Secondary ID [1] 0 0
COG-B971
Secondary ID [2] 0 0
B971
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumors 0 0
Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - DNA ploidy analysis
Other interventions - comparative genomic hybridization
Other interventions - cytogenetic analysis
Other interventions - fluorescence in situ hybridization

Other interventions: DNA ploidy analysis


Other interventions: comparative genomic hybridization


Other interventions: cytogenetic analysis


Other interventions: fluorescence in situ hybridization
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed primary CNS malignancy consistent with primitive
neuroectodermal tumor, medulloblastoma, or atypical teratoid/rhabdoid tumor

- Must be entered on CCG-9921, CCG-9931, CCG-A9961, CCG-99703 or other front-line
studies developed from CCG-90024 or CCG-90025

- Retrospective specimens also obtained from CCG-921, CCG-923, CCG-9892, CCG-9921, and
CCG-9931

PATIENT CHARACTERISTICS:

Age:

- Under 21

Performance status:

- See Disease Characteristics

Life expectancy:

- See Disease Characteristics

Hematopoietic:

- See Disease Characteristics

Hepatic:

- See Disease Characteristics

Renal:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- Not specified
Minimum age
No limit
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Georgia
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United States of America
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Illinois
Country [9] 0 0
United States of America
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Indiana
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Iowa
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Kentucky
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United States of America
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Michigan
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Minnesota
Country [14] 0 0
United States of America
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Missouri
Country [15] 0 0
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Nevada
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United States of America
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New Jersey
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United States of America
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North Carolina
Country [18] 0 0
United States of America
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North Dakota
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United States of America
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Ohio
Country [20] 0 0
United States of America
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Pennsylvania
Country [21] 0 0
United States of America
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South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
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United States of America
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Texas
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United States of America
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Utah
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Washington
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United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Saskatchewan

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
RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may
help doctors improve methods of diagnosing and treating children with brain tumors.

PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of
children with brain tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003096
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jaclyn A. Biegel, PhD
Address 0 0
Children's Hospital of Philadelphia
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/NCT00003096