Medpedia

• Non-Metastatic Ewings Sarcoma

-  INCLUSION CRITERIA:
Patients enrolled on COG AEWS0031 are eligible for this study.
EXCLUSION CRITERIA:
Patients who were enrolled but from whom samples were not obtained will not be enrolled on
this study.

BACKGROUND:  Clinical evidence for metastatic disease at the time of diagnosis is an
indicator of poor prognosis in Ewing's sarcoma. Patients with non-metastatic disease at
presentation are thought to have a better prognosis than those with metastatic disease.
Unfortunately, patients who appear non-metastatic at presentation may relapse after
initiating or completing standard therapy for Ewing's sarcoma. Evidence of metastatic
disease may be determined by radiographic studies and biopsy of potential site(s) of
disease. It is possible to identify submicroscopic Ewing's sarcoma cells in blood and bone
marrow, yet the prognostic value of this finding is unclear.

OBJECTIVES:  To determine the incidence of RT PCR positivity in the blood and bone marrow of
patients enrolled on COG AEWS0031 and to correlate the clinical outcome with RT PCR
positivity.

ELIGIBILITY:  Concurrent enrollment on COG AEWS0031.

DESIGN:  This is a Companion Biology Study, enrolling approximately 500 patients.  All
specimens will be evaluated for translocations, it is anticipated that approximately 30% of
specimens will have RT PCR positivity.  Specimens are collected at the time of diagnosis,
prior to cycle 2 chemotherapy, prior to initiation of local control, and at the end of
therapy/follow up.  Batched specimens are provided to the NIH by the Cooperative Human
Tissue Network (CHTN).  Following the completion of the COG trial and appropriate follow up
periods, RT PCR positivity will be compared with clinical outcome to determine prognostic
value.

• National Institutes of Health Clinical Center, 9000 Rockville Pike
  Bethesda, Maryland, 20892, United States
  Completed

• National Cancer Institute (NCI)
  Lead Sponsor
• United States: Federal Government

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