Method for Detecting an Increased Risk or Incidence of Colorectal Cancer

Abstract

The present invention relates to the methods and products for detection of colorectal cancer. Additionally, the present invention relates to methods and products for determining the probability, risk or incidence of colorectal cancer and of colorectal cancer metastasis. The products and methods of the present invention include detecting the level of expression of COL10A1 or MMP11, in combination, from samples, including tissue samples, from humans who currently have been diagnosed with cancer or who were previously diagnosed with cancer and those who are thought to have cancer and are undergoing diagnosis.

1 . A method for identifying or characterizing an individual at risk of or suffering from colorectal cancer, the method comprising:
 providing a sample from an individual whose risk or incidence of colorectal cancer is to be identified or characterized;   processing the sample to determine a level of COL10A1 and a level of MMP11; and   classifying the individual as having an elevated risk or incidence of colorectal cancer if the levels of COL10A1 and MMP11 are both elevated relative to a reference.   
     
     
         2 . The method of  claim 1 , wherein the individual comprises a human having colorectal cancer in stage UICC I. 
     
     
         3 . The method of  claim 1 , wherein the individual comprises a human having colorectal cancer in stage UICC II. 
     
     
         4 . The method of  claim 2 , wherein the risk or incidence of colorectal cancer comprises a risk of progressing to stage UICC III and/or IV. 
     
     
         5 . The method of  claim 1 , wherein the risk or incidence of colorectal cancer comprises a risk or incidence of colorectal cancer metastasis. 
     
     
         6 . The method of  claim 1 , wherein the risk or incidence of colorectal cancer comprises a risk or incidence of colorectal cancer recurrence. 
     
     
         7 . The method of  claim 1 , wherein the sample comprises human tumor tissue. 
     
     
         8 . The method of  claim 7 , wherein the sample is obtained from a primary colorectal tumor. 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 8 , wherein the step of processing comprises performing a PCR amplification of nucleic acids present in the sample. 
     
     
         12 . The method of  claim 8 , wherein the step of processing comprises performing a reverse transcriptase PCR amplification of nucleic acids present in the sample. 
     
     
         13 . The method of  claim 12 , wherein the reverse transcriptase PCR amplification is quantitative. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 8 , wherein the reference comprises a historical reference level of COL10A1 and MMP11 from the individual whose risk or incidence of colorectal cancer is to be identified or characterized. 
     
     
         16 . The method of  claim 8 , wherein the reference comprises levels of COL10A1 and MMP11 in a sample from an individual with a known risk or incidence of colorectal cancer. 
     
     
         17 . The method of  claim 16 , further comprising administering to the individual a therapeutically effective amount of an agent for treating incidence and/or risk of colorectal cancer. 
     
     
         18 . A method of treating an individual at risk of or suffering from colorectal cancer, the method comprising:
 administering to the individual a therapeutically effective amount of an agent for treating incidence and/or risk of colorectal cancer, wherein a sample from the individual has previously been determined to contain an elevated level of both COL10A1 and MMP11 relative to a reference.   
     
     
         19 . (canceled) 
     
     
         20 .- 29 . (canceled) 
     
     
         30 . A kit for classifying an individual as having an elevated risk of or suffering from colorectal cancer, the kit comprising primers for amplifying a region of COL10A1 and primers for amplifying a region of MMP11. 
     
     
         31 .- 36 . (canceled) 
     
     
         37 . A non-transitory computer readable medium containing executable instructions that when executed cause a processor to perform operations comprising:
 (a) receiving an individual's levels of COL10A1 and MMP11;   (b) determining whether the individual possesses elevated levels of COL10A1 and MMP11 relative to a reference; and   (c) classifying the individual as at risk of or suffering from colorectal cancer if the individual possesses elevated levels of COL10A1 and MMP11.   
     
     
         38 .- 44 . (canceled)