title: Development and independent validation of a prognostic assay for stage II colon cancer using formalin-fixed paraffin-embedded tissue.
abstract: OBJECTIVE
  Current prognostic factors are poor at identifying patients at risk of disease recurrence after surgery for stage II colon cancer. Here we describe a DNA microarray-based prognostic assay using clinically relevant formalin-fixed paraffin-embedded (FFPE) samples.
  
  
  METHODS
  A gene signature was developed from a balanced set of 73 patients with recurrent disease (high risk) and 142 patients with no recurrence (low risk) within 5 years of surgery.
  
  
  RESULTS
  The 634-probe set signature identified high-risk patients with a hazard ratio (HR) of 2.62 (P < .001) during cross validation of the training set. In an independent validation set of 144 samples, the signature identified high-risk patients with an HR of 2.53 (P < .001) for recurrence and an HR of 2.21 (P = .0084) for cancer-related death. Additionally, the signature was shown to perform independently from known prognostic factors (P < .001).
  
  
  CONCLUSIONS
  This gene signature represents a novel prognostic biomarker for patients with stage II colon cancer that can be applied to FFPE tumor samples.
authors: Centre for Cancer Research & Cell Biology, Queen's University Belfast, Northern Ireland, United Kingdom.
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authors: OF
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authors: Manne
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authors: Shanmugam
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authors: Richard H
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authors: Longley
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mesh_terms: D000368:Aged; D003110:Colonic Neoplasms / Q000235:genetics / Q000473:pathology*; D005260:Female; D005557:Formaldehyde; D020869:Gene Expression Profiling; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000235:genetics / Q000473:pathology*; D009367:Neoplasm Staging; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods; D016612:Paraffin Embedding / Q000379:methods* / Q000592:standards; D011379:Prognosis; D012189:Retrospective Studies; D012307:Risk Factors; D016707:Tissue Fixation
chemical_list: D005557:Formaldehyde