Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma
NCT ID: NCT00048984
Last Updated: 2013-06-24
Study Results
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Basic Information
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COMPLETED
637 participants
OBSERVATIONAL
2003-01-31
Brief Summary
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Detailed Description
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I. To develop a mechanism to collect and distribute tumor specimens to various investigators, and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken.
II. To determine the prognostic significance of translocation subtype in Ewing sarcoma; to determine the prognostic significance of translocation negative Ewing sarcoma.
III. To determine the prognostic significance of MRD detection in bone marrow specimens by RT-PCR determination of EWS-ETS fusion genes.
IV. To determine whether serum levels of IGF1, IGFBP3 are of significance in the outcome of patients with Ewing sarcoma.
V. To determine whether RNA expression profiles performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment in Ewing sarcoma.
VI. To identify new treatment targets for therapy. Further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinic.
VII. To establish a bank of Ewing sarcoma xenografts in SCID/Beige mice. VIII. To establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of Ewing sarcoma.
OUTLINE: This is a multicenter study.
Patients undergo various specimen collections, including bone marrow aspirate, paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens. These specimens are collected before, during, and after any chemotherapy regimens, during follow-up, and at time of recurrence. Translocation studies are performed on specimens to identify fusion genes, specifically EWS-ETS. Serum IGF1 and IFGBP3 levels are determined. Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Basic science (biomarker analysis)
Patients undergo various specimen collections, including bone marrow aspirate, paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens. These specimens are collected before, during, and after any chemotherapy regimens, during follow-up, and at time of recurrence. Translocation studies are performed on specimens to identify fusion genes, specifically EWS-ETS. Serum IGF1 and IFGBP3 levels are determined. Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction.
laboratory biomarker analysis
Correlative studies
Interventions
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laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Availability of the following specimens:
* Paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron) sections from initial biopsy
* Pretreatment serum and whole blood
* Concurrent therapy is not required
50 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Daniel West
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Oncology Group
Arcadia, California, United States
Countries
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Other Identifiers
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NCI-2012-02494
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000257115
Identifier Type: OTHER
Identifier Source: secondary_id
COG-AEWS02B1
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-03-C-0216
Identifier Type: OTHER
Identifier Source: secondary_id
AEWS02B1
Identifier Type: -
Identifier Source: org_study_id
NCT00063271
Identifier Type: -
Identifier Source: nct_alias
NCT00228774
Identifier Type: -
Identifier Source: nct_alias
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