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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01407744
First received: July 30, 2011
Last updated: July 12, 2013
Last verified: July 2013

July 30, 2011
July 12, 2013
March 2012
April 2013   (final data collection date for primary outcome measure)
  • PFS [ Time Frame: From the time of study enrollment to disease progression, disease relapse or death from any cause ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Association between OS and PFS with cell density, mitotic count, and tumor cell invasion [ Designated as safety issue: No ]
  • Correlation between hTERT expression and telomere dysfunction and PFS and OS [ Designated as safety issue: No ]
  • Role of 1q gain and 9p deletion and their association with PFS and OS [ Designated as safety issue: No ]
  • Frequency and clinicopathological associations of mutations in genes involved in Notch pathway signaling [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01407744 on ClinicalTrials.gov Archive Site
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Study of Tumor Samples From Patients With Ependymoma Treated on the Children's Oncology Group ACNS0121 Trial
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

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Archived tumor tissue

Non-Probability Sample

Patients with ependymoma treated on the Children Oncology Group ACNS0121 trial

  • Childhood Infratentorial Ependymoma
  • Childhood Supratentorial Ependymoma
  • Newly Diagnosed Childhood Ependymoma
Other: laboratory biomarker analysis
Correlative studies
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.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with ependymoma and treated on COG-ACNS0121
  • Previously collected tumor samples banked at the Children Oncology Group BioPathology
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01407744
ACNS11B1, NCI-2011-03801, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Uri Tabori Children's Oncology Group
Children's Oncology Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP