An observational study in Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, sponsored by Children's Oncology Group. Completed at 1 site in United States. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by Children's Oncology Group · Observational
This laboratory study is looking at tumor samples from patients with Ewing sarcoma. 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
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples collected from AEWS0031 and patients registered on AEWS08B1 Sampling Method: Non-Probability Sample
PRIMARY OBJECTIVES:
I. Determine if mutation of p53, and/or deletion of the p16 locus, have prognostic value in patients with Ewing sarcoma.
SECONDARY OBJECTIVES:
I. Estimate the incidence of p53 mutation in Ewing sarcoma samples collected from COG studies.
II. Estimate the incidence of p16 deletions in Ewing sarcoma samples collected from COG studies.
III. Prepare and archive amplified genomic DNA from Ewing sarcoma samples collected from COG studies for future biologic analysis.
OUTLINE: This is a multicenter study.
Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 200 is above the median of 121 across 238 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of Ewing sarcoma
Inclusion Criteria:
Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.
Other: laboratory biomarker analysis
Correlative studies
Event-free survival
Time frame: Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, assessed up to 3 years
Incidence of p53 mutations using the model of Sather and Sposto
Assessed using a two sided log rank test. The expected 95% confidence interval associated with this estimate, as a function of sample size and true mutation/deletion frequency is provided.
Time frame: Baseline
Incidence of p16 loss or deletion using the model of Sather and Sposto
Assessed using a two sided log rank test. The expected 95% confidence interval associated with this estimate, as a function of sample size and true mutation/deletion frequency is provided.
Time frame: Baseline
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group