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Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma

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ClinicalTrials.gov Identifier: NCT00048984
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Other: laboratory biomarker analysis

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 637 participants
Time Perspective: Prospective
Official Title: A Groupwide Biology and Banking Study for Ewing Sarcoma
Study Start Date : January 2003
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Success rate in which biomarker analyses can be carried out [ Time Frame: Up to 5 years ]
  2. Percent of the population on which biomarker analysis could be successfully conducted [ Time Frame: Up to 5 years ]
    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.

  3. Percent of submissions on which biomarker analysis could be successfully conducted [ Time Frame: Up to 5 years ]
    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.

  4. 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 ]
    The prevalence of these risk factors will be determined for the evaluable and nonevaluable samples to ensure the comparability of these two groups.


Biospecimen Retention:   Samples With DNA
Paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens

Eligibility Criteria
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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have Ewing's sarcoma
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048984


Locations
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United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Daniel West Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00048984    
Obsolete Identifiers: NCT00063271, NCT00228774
Other Study ID Numbers: AEWS02B1
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 )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Neoplasms
Sarcoma
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial