Prognostic Value of a Positive RT-PCR Test in Patients With Ewing Sarcoma
Condition: Non-Metastatic Ewings Sarcoma
MeSH terms: Sarcoma; Sarcoma, Ewing
Study type: Observational

Summary: 
      This study will determine whether the results of a test called reverse
      transcriptase-polymerase chain reaction (RT-PCR) correlate with clinical outcomes in patients
      with Ewing sarcoma, and if they can be used to help identify patients at high risk for
      metastasis (spread of the cancer beyond the original site).

      This is a companion study to another NCI trial (AEWS0031), which is examining the
      effectiveness of an intensified chemotherapy regimen for patients with Ewing sarcoma. The
      primary purposes of AEWS0031 are to determine: 1) if chemotherapy given every 2 weeks can
      cure more patients with Ewing sarcoma and similar tumors than chemotherapy given every 3
      weeks; and 2) if certain biological characteristics of these tumors can predict how well the
      chemotherapy will work.

      Many, but not all, patients with Ewing sarcoma that has not metastasized can be cured with
      standard radiation, surgery, and chemotherapy treatment. Most patients whose tumors have
      spread, however, are not cured with standard treatment. A goal of future therapy is to
      identify patients at highest risk for metastasis so that they can be given more intensive
      therapy, and, conversely, patients at lower risk of relapse can receive less toxic treatment.

      Patients enrolled in AEWS0031 are eligible for this companion study. No additional procedures
      re required; RT-PCR testing will be performed on blood and bone marrow samples collected for
      AEWS0031.

      ...
    

Detailed description: 
      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.
    

Keywords: Minimal Residual Disease; Ewings Sarcoma