Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma
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Purpose
RATIONALE: Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.
PURPOSE: Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma.
| Condition | Intervention |
|---|---|
|
Sarcoma |
Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Groupwide Biology and Banking Study for Ewing Sarcoma |
- Event Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Success rate in which biomarker analyses can be carried out [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Percent of the population on which biomarker analysis could be successfully conducted [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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.
- Percent of submissions on which biomarker analysis could be successfully conducted [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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.
- Relation to known prognostic factors including the presence or absence of metastatic disease, the site of disease, and other known risk factors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The prevalence of these risk factors will be determined for the evaluable and nonevaluable samples to ensure the comparability of these two groups.
| Enrollment: | 637 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Other: laboratory biomarker analysis
Correlative studies
Other Names:
|
Detailed Description:
OBJECTIVES:
- Determine the prognostic significance of chromosomal translocation subtype in patients with Ewing's sarcoma.
- Determine the prognostic significance of minimal residual disease detection in bone marrow of these patients, using reverse transcriptase-polymerase chain reaction determination of EWS-ETS fusion genes.
- Determine whether serum levels of IGF1 and IGFBP3 are of significance to outcome of these patients.
- Establish clinical proteomics for investigating altered signaling molecules in the pathogenesis of Ewing's 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.
PROJECTED ACCRUAL: A total of 470 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | up to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Newly diagnosed or recurrent Ewing's sarcoma
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
PATIENT CHARACTERISTICS:
Age
- 50 and under
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Show 163 Study Locations| Study Chair: | Daniel C. West, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00048984 History of Changes |
| Obsolete Identifiers: | NCT00063271, NCT00228774 |
| Other Study ID Numbers: | AEWS02B1, NCI-03-C-0216, CDR0000257115, COG-AEWS02B1 |
| Study First Received: | November 12, 2002 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Children's Oncology Group:
|
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Additional relevant MeSH terms:
|
Neuroectodermal Tumors, Primitive Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on June 17, 2013