Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of Stored Tumor Samples in Young Patients With Brain Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00897286
First received: May 9, 2009
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Condition
Brain and Central Nervous System Tumors

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular and Histopathologic Characterization of Atypical Teratoid Rhabdoid Tumors, Choroid Plexus Carcinomas, Ependymomas, Medulloblastoma/PNET and Gliomas of the Pediatric CNS

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Relationship between molecular abnormalities and tumor histologic and clinical characteristics [ Time Frame: 20 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Fresh frozen, fixed and cultured tumor cells collected prospectively from a clinically well characterized patient cohort.

Estimated Enrollment: 500
Study Start Date: November 2004
Estimated Study Completion Date: February 2026
Estimated Primary Completion Date: February 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tumor/Tissue Sample
Tumor material collected prospectively from a clinically well characterized patient cohort

Detailed Description:
The overall objective of this non-therapeutic protocol is to identify molecular abnormalities within prospectively treated pediatric CNS develop xenograft and in vitro models derived from Atypical Teratoid Rhabdoid Tumors (ATRT), Choroid Plexus Carcinomas (CPC), Ependymoma and high-grade gliomas. The investigators will characterize the genome-wide mutation, expression and epigenetic signatures of these models and compare them with the primary tumors from which they were derived, thus creating well-characterized and invaluable resource for research on these rare and deadly pediatric brain tumors. This will also provide important insights into intratumoral heterogeneity, and molecular abnormalities that may influence the selective pressures driving evolution, and tumor growth as xenografts or in vitro. and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and protein epigenome analysis tools to the study of fresh frozen, fixed and cultured tumor cells and xenografts. The establishment of cell cultures from each tumor sample will also allow for in vitro and in vivo analysis of tumor cell growth, signaling and therapeutic response.
  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will have ATRT, CPC, medulloblastoma/PNET, ependymoma or glioma of the CNS as documented by the local neuropathologist. All studies will be conducted using tumor material collected prospectively from a clinically well characterized patient cohort.
Criteria

Inclusion Criteria

  • ATRT, CPC, medulloblastoma/PNET, ependymoma or glioma of the CNS as documented by the local neuropathologist. Tumor may be primary, progressive or recurrent CNS tumor including brain and/or spine. For fresh tissue, in some cases we must process the tissue before a final diagnosis is available. If a xenograft is established from a brain tumor that is later diagnosed to be a different histological subtype, we will store frozen viable cells for potential future use. Although rare, patients with ATRT may present with a primary renal and CNS tumor. In these instances samples will be collected from both the kidney and CNS tumor for analysis if available.
  • Tumor may be collected at surgery prior to histologic confirmation
  • Age not more than 21 years at the time of initial diagnosis.
  • Enrollment in the current version of the institution's banking protocol
  • Biological parent(s) of participant (child) whose tumor is studied on this protocol. These parents will be assigned to cohort P. The exclusion criteria below do not apply to this cohort.

Exclusion Criteria

  • Diagnosis of tumor outside the central nervous system.
  • Age greater than 21 years at the time of diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897286

Contacts
Contact: Tabatha E. Doyle, RN 901-595-2544 tabatha.doyle@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Tabatha E. Doyle, RN    901-595-2544    tabatha.doyle@stjude.org   
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Amar Gajjar, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00897286     History of Changes
Other Study ID Numbers: NBTP01 
Study First Received: May 9, 2009
Last Updated: August 19, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
childhood atypical teratoid/rhabdoid tumor
childhood choroid plexus tumor
childhood medulloblastoma
recurrent childhood medulloblastoma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
recurrent childhood ependymoma
recurrent childhood supratentorial primitive neuroectodermal tumor
untreated childhood supratentorial primitive neuroectodermal tumor
gliomas

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Ependymoma
Medulloblastoma
Rhabdoid Tumor
Neoplasms by Site
Neoplasms
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on September 23, 2016