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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
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Secondary ID [1]
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NCI-2009-00334
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Secondary ID [2]
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ACNS02B3
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Atypical Teratoid/Rhabdoid Tumor
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Childhood Central Nervous System Germ Cell Tumor
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Childhood Cerebral Anaplastic Astrocytoma
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Childhood Cerebral Astrocytoma
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Childhood Choroid Plexus Neoplasm
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Childhood Craniopharyngioma
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Childhood Grade I Meningioma
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Childhood Grade II Meningioma
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Childhood Grade III Meningioma
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Childhood Infratentorial Ependymoma
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Childhood Oligodendroglioma
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Childhood Supratentorial Ependymoma
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Ependymoma
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Newly Diagnosed Childhood Ependymoma
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Recurrent Childhood Cerebellar Astrocytoma
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Recurrent Childhood Cerebral Astrocytoma
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Recurrent Childhood Ependymoma
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Recurrent Childhood Medulloblastoma
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Recurrent Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified
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Recurrent Childhood Visual Pathway Glioma
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Neurological
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Other neurological disorders
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Cancer
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Kidney
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Cancer
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Children's - Other
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Cancer
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Bone
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Collection of brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children?s Oncology Group institutions
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Assessment method [1]
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Timepoint [1]
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Up to 16 years
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Primary outcome [2]
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Creation of a repository for long-term storage of these specimens
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Assessment method [2]
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Timepoint [2]
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Up to 16 years
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Primary outcome [3]
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Making these specimens available to qualified researchers to understand the biology of pediatric brain tumors
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Assessment method [3]
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Timepoint [3]
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Up to 16 years
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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
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Minimum age
No limit
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Maximum age
18
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/02/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2018
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Sample size
Target
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Accrual to date
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Final
1258
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Hunter Regional Mail Centre
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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Royal Children's Hospital-Brisbane - Herston
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Recruitment hospital [4]
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Lady Cilento Children's Hospital - South Brisbane
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Women's and Children's Hospital-Adelaide - North Adelaide
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Recruitment hospital [6]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2310 - Hunter Regional Mail Centre
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5006 - North Adelaide
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Recruitment postcode(s) [5]
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6008 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Alberta
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British Columbia
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Manitoba
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San Juan
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00919750
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Scott Pomeroy
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Address
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Children's Oncology Group
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Phone
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00919750
Download to PDF