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

• ClinicalTrials.gov Identifier: NCT00919750
• Recruitment Status: Completed
• First Posted: June 12, 2009
• Last Update Posted: July 16, 2018
• Sponsor: Children's Oncology Group
• 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

• 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

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: United States, Australia, Canada, New Zealand, Puerto Rico, Switzerland

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