Pancreatic Cancer Biomarkers and Uses Thereof

Abstract

The present disclosure includes biomarkers, methods, devices, reagents, systems, and kits for the detection and diagnosis of cancer generally and pancreatic cancer specifically. In one aspect, the disclosure provides biomarkers that can be used alone or in various combinations to diagnose cancer generally or pancreatic cancer specifically. In another aspect, methods are provided for diagnosing pancreatic cancer in an individual, where the methods include detecting, in a biological sample from an individual, at least one biomarker value corresponding to at least one biomarker selected from the group of biomarkers provided in Table 1, wherein the individual is classified as having pancreatic cancer, or the likelihood of the individual having pancreatic cancer is determined, based on the at least one biomarker value. In a further aspect, methods are provided for diagnosing cancer generally in an individual, where the methods include detecting, in a biological sample from an individual, at least one biomarker value corresponding to at least one biomarker selected from the group of biomarkers provided in Table 19, wherein the individual is classified as having cancer generally, or the likelihood of the individual having cancer is determined, based on the at least one biomarker value.

1 - 35 . (canceled) 
     
     
         36 . A method for diagnosing pancreatic cancer in an individual, the method comprising:
 contacting a biological sample from the individual with at least N aptamers, wherein each aptamer has specific affinity for a protein biomarker corresponding to one of at least N biomarkers selected from Table 1, measuring the levels of the at least N protein biomarkers in the biological sample with an aptamer based assay; and wherein the levels of the at least N protein biomarkers provides an indication as to the likelihood that the individual does or does not have pancreatic cancer, and wherein N=2.   
     
     
         37 . The method of  claim 36 , wherein the biological sample is selected from the group consisting of whole blood, plasma, serum and pancreatic fluid. 
     
     
         38 . The method of  claim 37 , wherein the biological sample is plasma. 
     
     
         39 . The method  claim 36 , wherein the biological sample is pancreatic tissue and wherein the levels derive from a histological or cytological analysis of the pancreatic tissue. 
     
     
         40 . The method of  claim 36 , wherein the individual is a human. 
     
     
         41 . The method of  claim 36 , wherein N=3, 4, 5, 6 or 7. 
     
     
         42 . The method of  claim 36 , wherein the individual is high risk for pancreatic cancer due to smoking, alcohol consumption or family history of pancreatic cancer. 
     
     
         43 . The method of  claim 36 , wherein the protein biomarkers are selected from Table 18. 
     
     
         44 . The method of  claim 36 , wherein the protein biomarkers are selected from Table 19. 
     
     
         45 . The method of  claim 36 , further comprising the protein biomarker CA19-9. 
     
     
         46 . The method according to  claim 36 , wherein likelihood of the individual having pancreatic cancer is determined based on the biomarker levels and at least one item of additional biomedical information corresponding to the individual. 
     
     
         47 . The method of  claim 46 , wherein said at least one item of additional biomedical information is independently selected from the group consisting of
 (a) information corresponding to the presence or absence of a pancreatic mass or other abdominal mass,   (b) information corresponding to physical descriptors of said individual,   (c) information corresponding to a change in weight of said individual,   (d) information corresponding to the ethnicity of said individual,   (e) information corresponding to the gender of said individual,   (f) information corresponding to said individual's smoking history,   (g) information corresponding to said individual's alcohol use history,   (h) information corresponding to said individual's occupational history,   (i) information corresponding to said individual's family history of pancreatic cancer or other cancer,   (j) information corresponding to the presence or absence in said individual of at least one genetic marker correlating with a higher risk of pancreatic cancer or cancer in said individual or a family member of said individual,   (k) information corresponding to clinical symptoms of said individual,   (l) information corresponding to other laboratory tests,   (m) information corresponding to gene expression values of said individual, and   (n) information corresponding to said individual's exposure to known carcinogens.   
     
     
         48 . A method for screening an asymptomatic high risk individual for pancreatic cancer, the method comprising:
 contacting a biological sample from the asymptomatic high risk individual with at least N aptamers, wherein each aptamer has specific affinity for a protein biomarker corresponding to one of at least N biomarkers selected from Table 1, measuring the levels of the at least N protein biomarkers in the biological sample with an aptamer based assay; and wherein the levels of the at least N protein biomarkers provides an indication as to the likelihood that the asymptomatic high risk individual does or does not have pancreatic cancer, and wherein N=2.   
     
     
         49 . The method of  claim 48 , wherein the biological sample is selected from the group consisting of whole blood, plasma, serum and pancreatic fluid. 
     
     
         50 . The method of  claim 49 , wherein the biological sample is plasma. 
     
     
         51 . The method of  claim 48 , wherein the individual is a human. 
     
     
         52 . The method of  claim 48 , wherein N=3, 4, 5, 6 or 7. 
     
     
         53 . The method of  claim 48 , wherein the individual is high risk for pancreatic cancer due to smoking, alcohol consumption or family history of pancreatic cancer. 
     
     
         54 . The method according to  claim 48 , wherein likelihood of the individual having pancreatic cancer is determined based on the biomarker levels and at least one item of additional biomedical information corresponding to the individual. 
     
     
         55 . The method of  claim 54 , wherein said at least one item of additional biomedical information is independently selected from the group consisting of
 (a) information corresponding to the presence or absence of a pancreatic mass or other abdominal mass,   (b) information corresponding to physical descriptors of said individual,   (c) information corresponding to a change in weight of said individual,   (d) information corresponding to the ethnicity of said individual,   (e) information corresponding to the gender of said individual,   (f) information corresponding to said individual's smoking history,   (g) information corresponding to said individual's alcohol use history,   (h) information corresponding to said individual's occupational history,   (i) information corresponding to said individual's family history of pancreatic cancer or other cancer,   (j) information corresponding to the presence or absence in said individual of at least one genetic marker correlating with a higher risk of pancreatic cancer or cancer in said individual or a family member of said individual,   (k) information corresponding to clinical symptoms of said individual,   (l) information corresponding to other laboratory tests,   (m) information corresponding to gene expression values of said individual, and   (n) information corresponding to said individual's exposure to known carcinogens.