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Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors

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ClinicalTrials.gov Identifier: NCT00919750
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date June 11, 2009
First Posted Date June 12, 2009
Last Update Posted Date July 16, 2018
Actual Study Start Date February 16, 2004
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2018)
  • Collection of brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children?s Oncology Group institutions [ Time Frame: Up to 16 years ]
  • Creation of a repository for long-term storage of these specimens [ Time Frame: Up to 16 years ]
  • Making these specimens available to qualified researchers to understand the biology of pediatric brain tumors [ Time Frame: Up to 16 years ]
Original Primary Outcome Measures
 (submitted: June 11, 2009)
  • Collection of brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children's Oncology Group institutions
  • Creation of a repository for long-term storage of these specimens
  • Making these specimens available to qualified researchers to understand the biology of pediatric brain tumors
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
Official Title A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens
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.
Detailed Description

OBJECTIVES:

I. Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children?s Oncology Group institutions.

II. Provide a repository for long-term storage of specimens from these patients.

III. Make these specimens available to qualified researchers to understand the biology of pediatric brain tumors.

OUTLINE: This is a multicenter study.

Brain tumor tissue and blood specimens are collected from patients and banked for future study.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Childhood Atypical Teratoid/Rhabdoid Tumor
  • Childhood Central Nervous System Germ Cell Tumor
  • Childhood Cerebral Anaplastic Astrocytoma
  • Childhood Cerebral Astrocytoma
  • Childhood Choroid Plexus Neoplasm
  • Childhood Craniopharyngioma
  • Childhood Grade I Meningioma
  • Childhood Grade II Meningioma
  • Childhood Grade III Meningioma
  • Childhood Infratentorial Ependymoma
  • Childhood Oligodendroglioma
  • Childhood Supratentorial Ependymoma
  • Ependymoma
  • Newly Diagnosed Childhood Ependymoma
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified
  • Recurrent Childhood Visual Pathway Glioma
Intervention Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling
Study Groups/Cohorts Ancillary-Correlative (tissue and blood sample collection)
Brain tumor tissue and blood specimens are collected from patients and banked for future study.
Intervention: Other: Cytology Specimen Collection Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 12, 2018)
1258
Original Enrollment Not Provided
Actual Study Completion Date June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00919750
Other Study ID Numbers ACNS02B3
NCI-2009-00334 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ACNS02B3
CDR0000352347
ACNS02B3 ( Other Identifier: Childrens Oncology Group )
ACNS02B3 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Scott Pomeroy Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date July 2018