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

C

Children's Oncology Group

Status

Completed

Conditions

Newly Diagnosed Childhood Ependymoma
Childhood Infratentorial Ependymoma
Childhood Supratentorial Ependymoma

Treatments

Other: laboratory biomarker analysis

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01407744
NCI-2011-03801 (Registry Identifier)
ACNS11B1
U10CA098543 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

1 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Diagnosed with ependymoma and treated on COG-ACNS0121
  • Previously collected tumor samples banked at the Children Oncology Group BioPathology

Trial design

80 participants in 1 patient group

Correlative studies
Description:
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.
Treatment:
Other: laboratory biomarker analysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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