Gene expression markers for colorectal cancer prognosis

Abstract

A method of predicting clinical outcome in a subject diagnosed with colorectal cancer comprising determining evidence of the expression of one or more predictive RNA transcripts or their expression products in a biological sample of cancer cells obtained from the subject.

1 - 44 . (canceled) 
     
     
         45 . A method of predicting clinical outcome for a human subject diagnosed with colorectal cancer, comprising:
 determining a normalized expression level of an RNA transcript of BGN, FAP, INHBA, GADD45B, Ki-67, CMYC, and MYBL2, or an expression product thereof, in a biological sample comprising cancer cells obtained from said human subject, and;   predicting the likelihood of a positive clinical outcome for said human subject based on said normalized expression level of an RNA transcript of BGN, FAP, INHBA, GADD45B, Ki-67, CMYC, and MYBL2, or an expression product thereof,   wherein said normalized expression level of an RNA transcript of each of BGN, FAP, INHBA, and GADD45B, or an expression product thereof, is negatively correlated with an increased likelihood of a positive clinical outcome; and   wherein said normalized expression of each of Ki-67, CMYC, and MYBL2, or an expression product thereof, is positively correlated with an increased likelihood of a positive clinical outcome.   
     
     
         46 . The method of  claim 45 , wherein said normalized expression level of an RNA transcript of BGN, FAP, INHBA, GADD45B, Ki-67, CMYC, and MYBL2 is determined using a PCR-based method. 
     
     
         48 . The method of  claim 45 , wherein the sample is a formalin-fixed, paraffin-embedded tissue sample. 
     
     
         49 . The method of  claim 45 , wherein said clinical outcome is expressed in terms of Recurrence-Free Interval (RFI), Overall Survival (OS), Disease-Free Survival (DFS), or Distant Recurrence-Free Interval (DRFI). 
     
     
         50 . The method of  claim 45 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colorectal cancer. 
     
     
         51 . The method of  claim 45 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colon cancer. 
     
     
         52 . The method of  claim 45 , further comprising the step of creating a report summarizing said prediction. 
     
     
         53 . A method of predicting clinical outcome for a human subject diagnosed with colorectal cancer, comprising:
 determining a normalized expression level of an RNA transcript of BGN, FAP, and INHBA, or an expression product thereof, in a biological sample comprising cancer cells obtained from said human subject, and;   predicting the likelihood of a positive clinical outcome for said human subject based on said normalized expression level of an RNA transcript of BGN, FAP, and INHBA, or an expression product thereof, wherein said normalized expression level of an RNA transcript of each of BGN, FAP, and INHBA is negatively correlated with an increased likelihood of a positive clinical outcome.   
     
     
         54 . The method of  claim 53 , further comprising determining a normalized expression level of an RNA transcript, or an expression product thereof, of one or more of Ki-67, CMYC, MYBL2, and GADD45B in the biological sample;
 wherein said normalized expression level of each of Ki-67, CMYC, and MYBL2 is positively correlated with an increased likelihood of a positive clinical outcome; and   wherein said normalized expression level of GADD45B is negatively correlated with an increased likelihood of a positive clinical outcome.   
     
     
         55 . The method of  claim 53 , wherein said normalized expression level of an RNA transcript of BGN, FAP, and INHBA is determined using a PCR-based method. 
     
     
         56 . The method of  claim 53 , wherein the sample is a formalin-fixed, paraffin-embedded tissue sample. 
     
     
         57 . The method of  claim 53 , wherein said clinical outcome is expressed in terms of Recurrence-Free Interval (RFI), Overall Survival (OS), Disease-Free Survival (DFS), or Distant Recurrence-Free Interval (DRFI). 
     
     
         58 . The method of  claim 53 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colorectal cancer. 
     
     
         59 . The method of  claim 53 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colon cancer. 
     
     
         60 . A method of predicting clinical outcome for a human subject diagnosed with colorectal cancer, comprising:
 determining a normalized expression level of an RNA transcript of Ki-67, CMYC, and MYBL2, or an expression product thereof, in a biological sample comprising cancer cells obtained from said human subject, and;   predicting the likelihood of a positive clinical outcome for said human subject based on said normalized expression level of an RNA transcript of Ki-67, CMYC, and MYBL2, or an expression product thereof, wherein said normalized expression level of each of Ki-67, CMYC, and MYBL2 is positively correlated with an increased likelihood of a positive clinical outcome.   
     
     
         61 . The method of  claim 60 , further comprising determining a normalized expression level of an RNA transcript, or an expression product thereof, of one or more of BGN, FAP, INHBA, and GADD45B in the biological sample;
 wherein said normalized expression level of each of wherein said normalized expression level of an RNA transcript of each of BGN, FAP, INHBA, and GADD45B is negatively correlated with an increased likelihood of a positive clinical outcome.   
     
     
         62 . The method of  claim 60 , wherein said normalized expression level of an RNA transcript of Ki-67, CMYC, and MYBL2 is determined using a PCR-based method. 
     
     
         63 . The method of  claim 60 , wherein the sample is a formalin-fixed, paraffin-embedded tissue sample. 
     
     
         64 . The method of  claim 60 , wherein said clinical outcome is expressed in terms of Recurrence-Free Interval (RFI), Overall Survival (OS), Disease-Free Survival (DFS), or Distant Recurrence-Free Interval (DRFI). 
     
     
         65 . The method of  claim 60 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colorectal cancer. 
     
     
         66 . The method of  claim 60 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colon cancer.