Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Clinical Trial
Official title:
Observational - Prognostic Value of p53 and/or p16 Alterations in Ewing Sarcoma
Verified date | November 2015 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | 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
Status | Recruiting |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | January 2100 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 50 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Ewing sarcoma - Banked specimens from patients enrolled on AEWS0031 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Oncology Group | Monrovia | 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 | 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 | No | |
Secondary | 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. | Baseline | No |
Secondary | 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. | Baseline | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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