We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Collecting and Storing Biological Samples From Patients With Ewing Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00899990
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
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

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 908 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A COG Study for Collecting and Banking Ewing Sarcoma Specimens
Actual Study Start Date : February 4, 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Banking of biological specimens, including associated demographic and clinical data [ Time Frame: Not Provided ]

Biospecimen Retention:   Samples With DNA
Tissue, blood, and bone marrow

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with either newly diagnosed or recurrent Ewing sarcoma (including peripheral PNET and Askin tumor) are eligible for AEWS07B1.
Criteria

Inclusion Criteria:

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

    • Newly diagnosed or recurrent disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899990


Locations
Show Show 189 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Stephen L Lessnick Children's Oncology Group
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899990    
Other Study ID Numbers: AEWS07B1
NCI-2009-00370 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AEWS07B1
CDR0000544202
AEWS07B1 ( Other Identifier: Childrens Oncology Group )
AEWS07B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial