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

Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Clinical Trial

Official title:

A Groupwide Biology and Banking Study for Ewing Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048984
• Other study ID #: AEWS02B1
• Secondary ID: NCI-2012-02494CD
• Status: Completed
• Phase: N/A
• First received: November 12, 2002
• Last updated: June 20, 2013
• Start date: January 2003

Study information

• Verified date: June 2013
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00063271
• NCT00228774

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 50 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroectodermal Tumors, Primitive, Peripheral
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Sarcoma
• Sarcoma, Ewing

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Success rate in which biomarker analyses can be carried out		Up to 5 years	No
Secondary	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.	Up to 5 years	No
Secondary	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	No
Secondary	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	No