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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02494 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000257115 | Other Identifier | Clinical Trials.gov | |
| COG-AEWS02B1 | Other Identifier | Children's Oncology Group | |
| NCI-03-C-0216 | Other Identifier | NCI | |
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Univariate analysis using the proportional-hazards regression model will be used to formally assess the prognostic significance of each biological characteristic as it relates to risk for adverse event. Methods such as recursive partitioning adapted to survival analysis will be used to explore possible interactions between the presence of various markers and risk for adverse event. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate in which biomarker analyses can be carried out | Up to 5 years | |
| Percent of the population on which biomarker analysis could be successfully conducted | Determined by the number of patients on whom a definitive analytic result could be obtained, divided by the total number of patients enrolled after the test became part of the routine battery used by the investigators. |
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Inclusion Criteria:
Newly diagnosed or recurrent Ewing's sarcoma
Availability of the following specimens:
Concurrent therapy is not required
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Patients who have Ewing's sarcoma
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| Name | Affiliation | Role |
|---|---|---|
| Daniel West | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Arcadia | California | 91006-3776 | United States |
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Paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens
| Up to 5 years |
| Percent of submissions on which biomarker analysis could be successfully conducted | Determined by the number of patients on whom a definitive analytic result could be obtained, divided by the total number of patients for whom a specimen was submitted for the relevant assay. | Up to 5 years |
| Relation to known prognostic factors including the presence or absence of metastatic disease, the site of disease, and other known risk factors | The prevalence of these risk factors will be determined for the evaluable and nonevaluable samples to ensure the comparability of these two groups. | Up to 5 years |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| ID | Term |
|---|---|
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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