A Groupwide Biology and Banking Study for Ewing Sarcoma
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.
Observational
Time Perspective: Prospective
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
Daniel West
Principal Investigator
Children's Oncology Group
United States: Institutional Review Board
AEWS02B1
NCT00048984
January 2003
Name | Location |
---|---|
Children's Oncology Group | Arcadia, California 91006-3776 |