Collecting and Storing Biological Samples From Patients With Ewing Sarcoma

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00899990
First received: May 9, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone marrow, and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A COG Study for Collecting and Banking Ewing Sarcoma Specimens

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Banking of biological specimens, including associated demographic and clinical data [ Time Frame: Not Provided ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tumor specimens, bone marrow and peripheral blood


Estimated Enrollment: 700
Study Start Date: February 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (biomarker sampling)
Patients undergo collection of tumor specimens, bone marrow, and peripheral blood at diagnosis. Associated demographic and clinical data are collected and archived. Patients who are not enrolled on a therapeutic clinical trial are followed annually.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Collect biological specimens, including associated demographic and clinical data, from patients with Ewing sarcoma.

II. Provide a repository for long-term storage of Ewing sarcoma-related biological materials.

III. Make collected specimens available to qualified researchers to understand the biology of Ewing sarcoma and correlate these results with demographic and clinical data.

OUTLINE: This is a multicenter study.

Patients undergo collection of tumor specimens, bone marrow, and peripheral blood at diagnosis. Associated demographic and clinical data are collected and archived. Patients who are not enrolled on a therapeutic clinical trial are followed annually.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of Ewing sarcoma.

Criteria

Inclusion Criteria:

  • Diagnosis of Ewing sarcoma, including peripheral primitive neuroectodermal tumor and Askin tumor

    • Newly diagnosed or recurrent disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899990

  Show 176 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Stephen Lessnick, MD, PhD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899990     History of Changes
Other Study ID Numbers: AEWS07B1, NCI-2009-00370, COG-AEWS07B1, CDR0000544202, AEWS07B1, AEWS07B1, U10CA098543
Study First Received: May 9, 2009
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014