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

NCT00048984 | Completed

• 6 other identifiers: AEWS02B1NCI-2012-02494CDR0000257115COG-AEWS02B1NCI-03-C-0216U10CA098543
• Study Type: observational
• Target: 637
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Success rate in which biomarker analyses can be carried out

  Up to 5 years

• Percent of the population on which biomarker analysis could be successfully conducted

  Up to 5 years

• Percent of submissions on which biomarker analysis could be successfully conducted

  Up to 5 years

• Relation to known prognostic factors including the presence or absence of metastatic disease, the site of disease, and other known risk factors

  Up to 5 years

Study Arms (1)

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

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Basic science (biomarker analysis)

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who have Ewing's sarcoma

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive, Peripheral

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Daniel West

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2003
• Primary Completion: February 1, 2013
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)