Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Clinical Trial
Official title:
A Groupwide Biology and Banking Study for Ewing Sarcoma
Verified date | June 2013 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.
Status | Completed |
Enrollment | 637 |
Est. completion date | |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 50 Years |
Eligibility |
Inclusion Criteria: - Newly diagnosed or recurrent Ewing's sarcoma - Availability of the following specimens: - Paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron) sections from initial biopsy - Pretreatment serum and whole blood - Concurrent therapy is not required |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Oncology Group | Arcadia | California |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival | Univariate analysis using the proportional-hazards regression model will be used to formally assess the prognostic significance of each biological characteristic as it relates to risk for adverse event. Methods such as recursive partitioning adapted to survival analysis will be used to explore possible interactions between the presence of various markers and risk for adverse event. | 1 year | No |
Secondary | Success rate in which biomarker analyses can be carried out | Up to 5 years | No | |
Secondary | Percent of the population on which biomarker analysis could be successfully conducted | Determined by the number of patients on whom a definitive analytic result could be obtained, divided by the total number of patients enrolled after the test became part of the routine battery used by the investigators. | Up to 5 years | No |
Secondary | Percent of submissions on which biomarker analysis could be successfully conducted | Determined by the number of patients on whom a definitive analytic result could be obtained, divided by the total number of patients for whom a specimen was submitted for the relevant assay. | Up to 5 years | No |
Secondary | Relation to known prognostic factors including the presence or absence of metastatic disease, the site of disease, and other known risk factors | The prevalence of these risk factors will be determined for the evaluable and nonevaluable samples to ensure the comparability of these two groups. | Up to 5 years | No |
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