Protein signature/markers for the detection of adenocarcinoma

Abstract

The present invention provides a method for determining the presence of pancreatic adenocarcinoma in an individual and/or for determining the survival time of an individual afflicted with pancreatic adenocarcinoma comprising the steps of: (a) providing a serum or plasma sample to be tested; and (b) determining a protein signature of the test sample by measuring the presence and/or amount in the test sample of one or more selected proteins; wherein the presence and/or amount in the test sample of one or more proteins selected from the group defined in Table 1 is indicative of the presence of pancreatic adenocarcinoma. The invention also provides an array and a kit suitable for use in the methods of the invention.

1 . A method for determining the presence of pancreatic adenocarcinoma in an individual comprising the steps of:
 a) providing a serum or plasma sample to be tested;   b) determining a protein signature of the test sample by measuring the presence and/or amount in the test sample of one or more proteins selected from the group defined in Table 1;   wherein the presence and/or amount in the test sample of one or more proteins selected from the group defined in Table 1 is indicative of the presence of pancreatic adenocarcinoma.   
     
     
         2 . The method according to  claim 1  wherein the one or more proteins selected from the group defined in Table 1 includes IL-5 and C5. 
     
     
         3 . The method according to  claim 1  further comprising the steps of:
 c) providing a control serum or plasma sample from an individual not afflicted with pancreatic adenocarcinoma; 
 d) determining a protein signature of the control sample by measuring the presence and/or amount in the control sample of the one or more proteins measured in step (b); 
 wherein the presence of pancreatic adenocarcinoma is identified in the event that the presence and/or amount in the test sample of the one or more proteins measured in step (b) is different from the presence and/or amount in the control sample of the one or more proteins measured in step (b). 
 
     
     
         4 . The method according to  claim 1  wherein step (b) comprises measuring the presence and/or amount in the test sample of all of the proteins defined in Table 1. 
     
     
         5 . A method for determining the survival time of an individual afflicted with pancreatic adenocarcinoma comprising the steps of:
 i) providing a serum or plasma sample to be tested;   ii) determining a protein signature of the test sample by measuring the presence and/or amount in the test sample of one or more proteins selected from the group defined in Table 2;   wherein the survival time of an individual is identified in the event that the presence and/or amount in the test sample of one or more proteins selected from the group defined in Table 2 is indicative of a survival time of less than 12 months or longer than 12 months or longer than 24 months.   
     
     
         6 . The method according to  claim 5  further comprising the steps of:
 iii) providing a first control serum or plasma sample from an individual having a survival time of less than 12 months and/or a second control serum or plasma sample from an individual having a survival time longer than 12 months and/or longer than 24 months; 
 iv) determining a protein signature of the first and/or the second control sample by measuring the presence and/or amount of the one or more proteins measured in step (ii); 
 wherein the survival time of an individual is identified by comparing the presence and/or amount of the one or more proteins in the test sample measured in step (ii) with the presence and/or amount of the one or more proteins in the first and/or second control sample measured in step (iv). 
 
     
     
         7 . The method according to  claim 5  wherein step (ii) comprises measuring the presence and/or amount in the test sample of all of the proteins defined in Table 2. 
     
     
         8 . The method according to  claim 1  wherein step (b) and/or step (d) is performed using a first binding agent capable of binding to the one or more proteins. 
     
     
         9 . The method according to  claim 5  wherein step (ii) and/or step (iv) is performed using a first binding agent capable of binding to the one or more proteins. 
     
     
         10 . The method according to  claim 8  wherein the first binding agent is an antibody or a fragment thereof. 
     
     
         11 . The method according to  claim 9  wherein the first binding agent is an antibody or fragment thereof. 
     
     
         12 . (canceled) 
     
     
         13 . The method according to  claim 1  wherein the one or more proteins in the test sample is labelled with a detectable moiety. 
     
     
         14 . The method according to  claim 5  wherein the one or more proteins in the test sample is labelled with a detectable moiety. 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . The method according to  claim 1  wherein step (b) and/or step (d) is performed using an array. 
     
     
         18 . The method according to  claim 5  wherein step (ii) and/or step (iv) is performed using an array. 
     
     
         19 .- 21 . (canceled) 
     
     
         22 . The method according to  claim 1  wherein step (b) and/or step (d) is performed using an assay comprising a second binding agent capable of binding to the one or more proteins, the second binding agent having a detectable moiety. 
     
     
         23 . The method according to  claim 5  wherein step (ii) and/or step (iv) is performed using an assay comprising a second binding agent capable of binding to the one or more proteins, the second binding agent having a detectable moiety. 
     
     
         24 . The method according to  claim 22  wherein the second binding agent is an antibody or a fragment thereof. 
     
     
         25 . The method according to  claim 23  wherein the second binding agent is an antibody or fragment thereof. 
     
     
         26 .- 28 . (canceled) 
     
     
         29 . An array for determining the presence of pancreatic adenocarcinoma in an individual comprising one or more binding agent as defined in  claim 8 . 
     
     
         30 . An array according to  claim 29  wherein the one or more binding agent is capable of binding to all of the proteins defined in Table 1. 
     
     
         31 . An array for determining the survival time of an individual afflicted with pancreatic adenocarcinoma comprising one or more binding agent as defined in  claim 9 . 
     
     
         32 . An array according to  claim 31  wherein the one or more binding agent is capable of binding to all of the proteins defined in Table 2. 
     
     
         33 .- 42 . (canceled)