Study of Tumor Samples From Patients With Ewing Sarcoma

Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Clinical Trial

Official title:

Observational - Prognostic Value of p53 and/or p16 Alterations in Ewing Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00898053
• Other study ID #: AEWS08B1
• Secondary ID: NCI-2009-00372U1
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 6, 2015
• Start date: September 2008

Study information

• 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

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroectodermal Tumors, Primitive, Peripheral
• Sarcoma
• Sarcoma, Ewing

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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