Study of Tumor Samples From Patients With Ewing Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00898053
First received: May 9, 2009
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational - Prognostic Value of p53 and/or p16 Alterations in Ewing Sarcoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of p53 mutations using the model of Sather and Sposto [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

tumor samples


Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Correlative studies
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

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.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of Ewing sarcoma

Criteria

Inclusion Criteria:

  • Diagnosis of Ewing sarcoma
  • Banked specimens from patients enrolled on AEWS0031
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898053

Locations
United States, California
Children's Oncology Group Recruiting
Monrovia, California, United States, 91006-3776
Contact: Stephen L. Lessnick, MD       stephen.lessnick@hci.utah.edu   
Principal Investigator: Stephen L. Lessnick, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Stephen Lessnick, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898053     History of Changes
Other Study ID Numbers: AEWS08B1, NCI-2009-00372, U10CA098543
Study First Received: May 9, 2009
Last Updated: May 6, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Osteosarcoma

ClinicalTrials.gov processed this record on July 01, 2015