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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

Tracking Information
First Submitted Date November 12, 2002
First Posted Date January 27, 2003
Last Update Posted Date June 24, 2013
Study Start Date January 2003
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2013)
  • Success rate in which biomarker analyses can be carried out [ Time Frame: Up to 5 years ]
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma
Official Title A Groupwide Biology and Banking Study for Ewing Sarcoma
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.
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens
Sampling Method Probability Sample
Study Population Patients who have Ewing's sarcoma
Condition
  • Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Intervention Other: laboratory biomarker analysis
Correlative studies
Study Groups/Cohorts 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.
Intervention: Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2013)
637
Original Enrollment Not Provided
Study Completion Date Not Provided
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
Administrative Information
NCT Number NCT00048984
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Daniel West Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date June 2013