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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/NCT00919750




Registration number
NCT00919750
Ethics application status
Date submitted
11/06/2009
Date registered
12/06/2009
Date last updated
16/07/2018

Titles & IDs
Public title
Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
Scientific title
A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
Secondary ID [1] 0 0
NCI-2009-00334
Secondary ID [2] 0 0
ACNS02B3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Atypical Teratoid/Rhabdoid Tumor 0 0
Childhood Central Nervous System Germ Cell Tumor 0 0
Childhood Cerebral Anaplastic Astrocytoma 0 0
Childhood Cerebral Astrocytoma 0 0
Childhood Choroid Plexus Neoplasm 0 0
Childhood Craniopharyngioma 0 0
Childhood Grade I Meningioma 0 0
Childhood Grade II Meningioma 0 0
Childhood Grade III Meningioma 0 0
Childhood Infratentorial Ependymoma 0 0
Childhood Oligodendroglioma 0 0
Childhood Supratentorial Ependymoma 0 0
Ependymoma 0 0
Newly Diagnosed Childhood Ependymoma 0 0
Recurrent Childhood Cerebellar Astrocytoma 0 0
Recurrent Childhood Cerebral Astrocytoma 0 0
Recurrent Childhood Ependymoma 0 0
Recurrent Childhood Medulloblastoma 0 0
Recurrent Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified 0 0
Recurrent Childhood Visual Pathway Glioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Neurological 0 0 0 0
Other neurological disorders
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Bone
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure

Ancillary-Correlative (tissue and blood sample collection) - Brain tumor tissue and blood specimens are collected from patients and banked for future study.


Other interventions: Cytology Specimen Collection Procedure
Correlative studies
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Collection of brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children?s Oncology Group institutions
Timepoint [1] 0 0
Up to 16 years
Primary outcome [2] 0 0
Creation of a repository for long-term storage of these specimens
Timepoint [2] 0 0
Up to 16 years
Primary outcome [3] 0 0
Making these specimens available to qualified researchers to understand the biology of pediatric brain tumors
Timepoint [3] 0 0
Up to 16 years

Eligibility
Key inclusion criteria
- Diagnosis of brain tumor

- Previously treated at a Children?s Oncology Group (COG) institution

- Patients are eligible at time of diagnosis, second-look surgery, recurrence, or
development of a second malignant neoplasm

- Must have brain tumor biological specimens derived from primary tumors of the CNS
available for submission
Minimum age
No limit
Maximum age
18 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
16/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
Accrual to date
Final
1258
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [4] 0 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [5] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
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Connecticut
Country [7] 0 0
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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Florida
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Georgia
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United States of America
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maine
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Maryland
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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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United States of America
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New Jersey
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United States of America
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New Mexico
Country [31] 0 0
United States of America
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New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
Country [35] 0 0
United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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Texas
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United States of America
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Utah
Country [44] 0 0
United States of America
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Vermont
Country [45] 0 0
United States of America
State/province [45] 0 0
Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Washington
Country [47] 0 0
United States of America
State/province [47] 0 0
West Virginia
Country [48] 0 0
United States of America
State/province [48] 0 0
Wisconsin
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Canada
State/province [49] 0 0
Alberta
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Canada
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British Columbia
Country [51] 0 0
Canada
State/province [51] 0 0
Manitoba
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Canada
State/province [52] 0 0
Nova Scotia
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Canada
State/province [53] 0 0
Ontario
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Canada
State/province [54] 0 0
Quebec
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Canada
State/province [55] 0 0
Saskatchewan
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New Zealand
State/province [56] 0 0
Auckland
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Puerto Rico
State/province [57] 0 0
San Juan
Country [58] 0 0
Switzerland
State/province [58] 0 0
Geneva

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
The purpose of this study is to collect and store brain tissue samples and blood from
children with brain cancer that will be tested in the laboratory. Collecting and storing
samples of tumor tissue and blood from patients to test in the laboratory may help the study
of cancer in the future.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00919750
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Pomeroy
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/NCT00919750