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Completed

NCT Number: NCT00048984

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

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.

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Key information

Conditions

Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Age range

Up to 50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Arcadia, California, 91006-3776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Groupwide Biology and Banking Study for Ewing Sarcoma

Important dates

Study start
2003
Primary completion
2013
First posted
Jan 27, 2003
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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