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
3 other identifiers
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2011
CompletedFirst Posted
Study publicly available on registry
August 2, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMay 18, 2016
May 1, 2016
1.1 years
July 30, 2011
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients with ependymoma treated on the Children Oncology Group ACNS0121 trial
You may qualify if:
- Diagnosed with ependymoma and treated on COG-ACNS0121
- Previously collected tumor samples banked at the Children Oncology Group BioPathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Monrovia, California, 91006-3776, United States
Biospecimen
Archived tumor tissue
Study Officials
- PRINCIPAL INVESTIGATOR
Uri Tabori, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2011
First Posted
August 2, 2011
Study Start
March 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 18, 2016
Record last verified: 2016-05