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Biomarker in Tissue Samples From Patients With Ewing Sarcoma
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01365949
First received: June 1, 2011
Last updated: July 7, 2016
Last verified: July 2016
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | June 1, 2011 | |||
| Last Updated Date | July 7, 2016 | |||
| Start Date ICMJE | May 2011 | |||
| Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Frequency of INI1 protein loss in Ewing Sarcoma | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT01365949 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Biomarker in Tissue Samples From Patients With Ewing Sarcoma | |||
| Official Title ICMJE | 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. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray. |
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| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Retention: Samples With DNA Description: Tissue |
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| Sampling Method | Non-Probability Sample | |||
| Study Population | Diagnosis of Ewing sarcoma. | |||
| Condition ICMJE | Sarcoma | |||
| Intervention ICMJE |
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| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 40 | |||
| Completion Date | Not Provided | |||
| Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Sex/Gender |
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| Ages | up to 120 Years (Child, Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01365949 | |||
| Other Study ID Numbers ICMJE | 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 ) |
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| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Children's Oncology Group | |||
| Study Sponsor ICMJE | Children's Oncology Group | |||
| Collaborators ICMJE | National Cancer Institute (NCI) | |||
| Investigators ICMJE |
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| PRS Account | Children's Oncology Group | |||
| Verification Date | July 2016 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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