- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407744
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with ependymoma and treated on COG-ACNS0121
- Previously collected tumor samples banked at the Children Oncology Group BioPathology
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Correlative studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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PFS
Time Frame: From the time of study enrollment to disease progression, disease relapse or death from any cause
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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.
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From the time of study enrollment to disease progression, disease relapse or death from any cause
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OS
Time Frame: From the time of study enrollment to death from any cause
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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.
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From the time of study enrollment to death from any cause
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Uri Tabori, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACNS11B1
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2011-03801 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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