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Study of Tumor Samples From Patients With Ependymoma Treated on the Children's Oncology Group ACNS0121 Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407744
First Posted: August 2, 2011
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
This research trial studies tumor samples from patients with ependymoma treated on the Children Oncology Group ACNS0121 trial. 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. It may also help doctors find better ways to treat cancer.

Condition Intervention
Childhood Infratentorial Ependymoma Childhood Supratentorial Ependymoma Newly Diagnosed Childhood Ependymoma Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Examination of the Multiple Genetic and Molecular Targets as Therapeutic Options for Patients With Ependymoma Treated by the Phase II Children's Oncology Group Study ACNS0121

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • PFS [ Time Frame: From the time of study enrollment to disease progression, disease relapse or death from any cause ]
    The multivariable Cox model and cumulative incidence regression models will be used. Associations between the biology markers and outcome variables will be studied in a single-variable setting as well as via multivariable Cox models.

  • OS [ Time Frame: From the time of study enrollment to death from any cause ]
    The multivariable Cox model and cumulative incidence regression models will be used. Associations between the biology markers and outcome variables will be studied in a single-variable setting as well as via multivariable Cox models.


Biospecimen Retention:   Samples With DNA
Archived tumor tissue

Enrollment: 80
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Correlative studies
Archived tumor tissue samples are analyzed by laboratory biomarker analysis for cellular density, mitotic count, tumor cell invasion, hTERT expression, telomere dysfunction, 1q gain, 9p deletion, and genetic mutations by IHC, Affymetrix MIP arrays, and FISH. Results are then correlated with patient-outcome variables and known risk factors, namely gender, age at diagnosis, tumor location infratentorial vs. supratentorial), tumor grade (differentiated vs anaplastic), and extent of surgery as well as pathologic variables.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To examine the prognostic role of histopathological variables, in particular cellular density, mitotic count, and tumor cell invasion in intracranial pediatric ependymomas.

II. To study whether hTERT expression and telomere dysfunction correlate with progression-free survival (PFS) and overall survival (OS) in pediatric intracranial ependymoma.

III. To perform a genome-wide copy number screen and validation of copy number abnormalities (CNAs) on formalin-fixed paraffin-embedded (FFPE) ependymomas using Affymetrix Molecular Inversion Probe (MIP) arrays and interphase fluorescence in situ hybridization (iFISH). IV. To evaluate associations between infiltration of immune markers and PFS as well as OS in pediatric ependymoma.

V. To examine the role of 1q gain and 9p deletion in pediatric ependymomas by exploring their association with PFS and OS in a multivariable model.

VI. To establish the frequency and clinicopathological associations of mutations in genes involved in Notch pathway signaling.

OUTLINE:

Archived tumor tissue samples are analyzed for cellular density, mitotic count, tumor cell invasion, hTERT expression, telomere dysfunction, 1q gain, 9p deletion, and genetic mutations by IHC, Affymetrix Molecular Inversion Probe (MIP) arrays, and fluorescence in situ hybridization (FISH). Results are then correlated with patient-outcome variables and known risk factors, namely gender, age at diagnosis, tumor location infratentorial vs. supratentorial), tumor grade (differentiated vs anaplastic), and extent of surgery as well as pathologic variables.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ependymoma treated on the Children Oncology Group ACNS0121 trial
Criteria

Inclusion Criteria:

  • Diagnosed with ependymoma and treated on COG-ACNS0121
  • Previously collected tumor samples banked at the Children Oncology Group BioPathology
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407744


Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Uri Tabori, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01407744     History of Changes
Other Study ID Numbers: ACNS11B1
NCI-2011-03801 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: July 30, 2011
First Posted: August 2, 2011
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue