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

Childhood Infratentorial Ependymoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407744
• Other study ID #: ACNS11B1
• Secondary ID: NCI-2011-03801U1
• Status: Completed
• Phase: N/A
• First received: July 30, 2011
• Last updated: May 16, 2016
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

Inclusion Criteria:

• Diagnosed with ependymoma and treated on COG-ACNS0121

• Previously collected tumor samples banked at the Children Oncology Group BioPathology

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Childhood Infratentorial Ependymoma
• Childhood Supratentorial Ependymoma
• Ependymoma
• Newly Diagnosed Childhood Ependymoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	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.	From the time of study enrollment to disease progression, disease relapse or death from any cause	No
Primary	OS	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.	From the time of study enrollment to death from any cause	No