Protein biomarker panels for detecting colorectal cancer and advanced adenoma

Abstract

Disclosed herein are panels related to the diagnosis or recognition of colon and colorectal cancer in a subject. The disclosed panels and related methods are used to predict or assess colon tumor status in a patient. They can be used to determine nature of tumor, recurrence, or patient response to treatments. Some embodiments of the methods include generating a report for clinical management.

What is claimed is: 
     
         1 . A method of assessing a colorectal cancer risk status in an individual, comprising the steps of
 obtaining a circulating blood sample from the individual;   obtaining a biomarker panel level for a biomarker panel comprising a list of proteins in the sample comprising AACT, CO3, CO9, MIF, and PSGL to comprise panel information from said individual;   comparing said panel information from said individual to a reference panel information set corresponding to a known colorectal cancer status;   and categorizing said individual as having said colorectal cancer risk status if said individual's reference panel information does not differ significantly from said reference panel information set.   
     
     
         2 . The method of  claim 1 , wherein obtaining a circulating blood sample comprises drawing blood from a vein or artery of the individual 
     
     
         3 . The method of  claim 1 , wherein the panel information comprises age information for the individual. 
     
     
         4 . The method of  claim 1 , wherein the list of proteins comprises AACT, CO3, CO9, MIF, PSGL, CATD, CEA and SEPR. 
     
     
         5 . The method of  claim 1 , wherein the categorizing has a sensitivity of at least 81% and a specificity of at least 78%. 
     
     
         6 . The method of  claim 1 , comprising transmitting a report of results of said categorizing to a health practitioner. 
     
     
         7 . The method of  claim 6 , wherein the report recommends that a colonoscopy be performed. 
     
     
         8 . The method of  claim 1 , wherein the individual undergoes a colonoscopy. 
     
     
         9 . The method of  claim 1 , wherein no parameter of said individual's reference panel information in isolation is indicative of said colorectal cancer status in said individual at a sensitivity of greater than 65% or a specificity of greater than 65%. 
     
     
         10 . The method of  claim 1 , wherein the obtaining protein levels comprises contacting a fraction of the circulating blood sample to a set of antibodies, wherein the set of antibodies comprises antibodies specific to AACT, CO3, CO9, MIF, and PSGL. 
     
     
         11 . A method of monitoring efficacy of a colorectal cancer treatment regimen in an individual, comprising the steps of
 obtaining a first sample comprising circulating blood from the individual at a first time point;   administering the treatment regimen to the individual;   obtaining a second sample comprising circulating blood from the individual at a second time point;   obtaining a first panel level comprising protein levels for a list of proteins in the first sample and a second panel level comprising protein levels for a list of proteins in the second sample, said list comprising AACT, CO3, CO9, MIF, and PSGL to comprise panel information for said first sample and said second sample;   wherein a change in protein levels indicates efficacy of the colorectal cancer treatment.   
     
     
         12 . The method of  claim 11 , wherein obtaining the first sample comprises drawing blood from a vein or artery of the individual. 
     
     
         13 . The method of  claim 11 , wherein the treatment regimen comprises a colonoscopy. 
     
     
         14 . The method of  claim 11 , wherein the list of proteins comprises AACT, CO3, CO9, MIF, PSGL, CATD, CEA and SEPR. 
     
     
         15 . The method of  claim 11 , comprising changing the treatment regimen if no efficacy is indicated. 
     
     
         16 . The method of  claim 11 , comprising repeating the treatment regimen if no efficacy is indicated. 
     
     
         17 . The method of  claim 11 , comprising discontinuing the treatment regimen if efficacy is indicated. 
     
     
         18 . A method of assessing an advanced adenoma risk status in an individual, comprising the steps of
 obtaining a circulating blood sample from the individual;   obtaining protein levels for a list of proteins relevant to advanced adenoma in the sample comprising at least three of CATD, CLUS, GDF15 and SAA1 to comprise biomarker panel information from said individual;   comparing said panel information from said individual to a reference panel information set corresponding to a known advanced adenoma status;   and categorizing said individual as having said advanced adenoma risk status if said individual's reference panel information does not differ significantly from said reference panel information set.   
     
     
         19 . The method of  claim 18 , wherein obtaining a circulating blood sample comprises drawing blood from a vein or artery of the individual 
     
     
         20 . The method of  claim 18 , wherein the panel information comprises age information for the individual. 
     
     
         21 . The method of  claim 18 , comprising transmitting a report of results of said categorizing to a healthcare professional. 
     
     
         22 . The method of  claim 18 , wherein the individual undergoes a colonoscopy. 
     
     
         23 . A method of assessing a colorectal health risk status in an individual, comprising the steps of
 obtaining a circulating blood sample from the individual;   obtaining a biomarker panel level for a biomarker panel comprising a list of proteins in the sample comprising AACT, CO3, CO9, MIF, PSGL, SEPR, CEA, CATD, CLUS, GDF15 and SAA1, and obtaining an age for the individual,   wherein AACT, CO3, CO9, MIF, PSGL, SEPR, CEA, CATD, and age comprise colorectal cancer panel information from said individual;   and wherein CATD, CLUS, GDF15 and SAA1 comprise advanced adenoma panel information from said individual;   comparing said colorectal cancer panel information from said individual to a reference colorectal cancer panel information set corresponding to a known colorectal cancer status;   comparing said advanced adenoma panel information from said individual to a reference advanced adenoma panel information set corresponding to a known advanced adenoma status;   and categorizing said individual as having a colorectal health risk if either of said colorectal cancer panel or said advanced adenoma panel does not differ significantly from a reference panel positive for a colorectal health risk.   
     
     
         24 . The method of  claim 23 , wherein obtaining a circulating blood sample comprises drawing blood from a vein or artery of the individual. 
     
     
         25 . The method of  claim 23 , wherein the list of proteins comprises no more than 20 proteins. 
     
     
         26 . The method of  claim 23 , comprising transmitting a report of results of said categorizing to a health practitioner. 
     
     
         27 . The method of  claim 26 , wherein the report recommends that a colonoscopy be performed. 
     
     
         28 . The method of  claim 23 , wherein the individual undergoes a colonoscopy. 
     
     
         29 . The method of  claim 26 , wherein the individual undergoes a stool cancer assay. 
     
     
         30 . The method of  claim 26 , wherein the obtaining protein levels comprises contacting a fraction of the circulating blood sample to a set of antibodies, wherein the set of antibodies comprises antibodies specific to AACT, CO3, CO9, MIF, PSGL, SEPR, CEA, CATD, CLUS, GDF15 and SAA1.