Biomarker in Tissue Samples From Patients With Ewing Sarcoma

Tracking Information
First Submitted Date	June 1, 2011
First Posted Date	June 3, 2011
Last Update Posted Date	July 11, 2016
Study Start Date	May 2011
Actual Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 1, 2011)	Frequency of INI1 protein loss in Ewing Sarcoma
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01365949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Biomarker in Tissue Samples From Patients With Ewing Sarcoma
Official Title	INI-1 Deletions in Ewing Sarcoma
Brief Summary	RATIONALE: Studying samples of 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. PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing sarcoma.
Detailed Description	OBJECTIVES: To determine the frequency of INI-1 protein loss in Ewing Sarcoma. OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Tissue
Sampling Method	Non-Probability Sample
Study Population	Diagnosis of Ewing sarcoma.
Condition	Sarcoma
Intervention	Genetic: microarray analysis; Genetic: protein analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: June 1, 2011)	40
Original Estimated Enrollment	Same as current
Study Completion Date	Not Provided
Actual Primary Completion Date	July 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria	DISEASE CHARACTERISTICS: Diagnosis of Ewing sarcoma; Prepared tissue microarray with Ewing sarcoma samples available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 120 Years (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT01365949
Other Study ID Numbers	AEWS11B1; COG-AEWS11B1 ( Other Identifier: Children's Oncology Group ); NCI-2011-02857 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); AEWS11B1 ( Other Identifier: Children's Oncology Group )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Children's Oncology Group
Study Sponsor	Children's Oncology Group
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: Joshua D. Schiffman, MD University of Utah
PRS Account	Children's Oncology Group
Verification Date	July 2016