Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 50 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Ewing sarcoma * Banked specimens from patients enrolled on AEWS0031
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of p53 mutations using the model of Sather and Sposto | Baseline | 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. |
| Incidence of p16 loss or deletion using the model of Sather and Sposto | Baseline | 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. |
Countries
United States
Outcome results
None listed