Biomarkers and methods for diagnosis of early stage pancreatic ductal adenocarcinoma

Abstract

The present invention provides biomarker compositions and methods for the diagnosis and prognosis of PDAC. In a particular embodiment, the invention provides methods and compositions for screening, diagnosis and prognosis of early stage, asymptomatic PDAC.

What is claimed is: 
     
         1 . A panel of isolated biomarkers comprising N of the biomarkers listed in Tables 1 through 4. 
     
     
         2 . The panel of  claim 1 , wherein N is a number selected from the group consisting of 2 to 30. 
     
     
         3 . The panel of  claim 2 , wherein said panel comprises at least two isolated biomarkers selected from the group consisting of the biomarkers set forth in Tables 1 through 4. 
     
     
         4 . The panel of  claim 2 , wherein said panel comprises basigin (BSG). 
     
     
         5 . The panel of  claim 2 , wherein said panel comprises soluble hyaluronic acid (HA). 
     
     
         6 . A method of determining a probability for early stage pancreatic ductal adenocarcinoma (PDAC) in an individual, the method comprising detecting a measurable feature of each of N biomarkers selected from the biomarkers listed in Tables 1 through 4 in a biological sample obtained from said individual, and analyzing said measurable feature to determine the probability for early stage PDAC in said individual. 
     
     
         7 . The method of  claim 6 , wherein said measurable feature comprises fragments or derivatives of each of said N biomarkers selected from the biomarkers listed in Tables 1 through 4. 
     
     
         8 . The method of  claim 6 , wherein said detecting a measurable feature comprises quantifying an amount of each of N biomarkers selected from the biomarkers listed in Tables 1 through 4, combinations or portions and/or derivatives thereof in a biological sample obtained from said individual. 
     
     
         9 . The method of  claim 8 , further comprising calculating the probability for early stage PDAC in said individual based on said quantified amount of each of N biomarkers selected from the biomarkers listed in Tables 1 through 4. 
     
     
         10 . The method of  claim 6 , further comprising an initial step of providing a biomarker panel comprising N of the biomarkers listed in Tables 1 through 4. 
     
     
         11 . The method of  claim 6 , further comprising an initial step of providing a biological sample from the individual. 
     
     
         12 . The method of  claim 6 , further comprising communicating said probability to a health care provider. 
     
     
         13 . The method of  claim 12 , wherein said communication informs a subsequent treatment decision for said individual. 
     
     
         14 . The method of  claim 6 , wherein N is a number selected from the group consisting of 2 to 30. 
     
     
         15 . The method of  claim 14 , wherein said N biomarkers comprise basigin (BSG). 
     
     
         16 . The method of  claim 14 , wherein said N biomarkers comprise soluble hyaluronic acid (HA). 
     
     
         17 . The method of  claim 6 , wherein said analysis comprises a use of a predictive model. 
     
     
         18 . The method of  claim 17 , wherein said analysis comprises comparing said measurable feature with a reference feature. 
     
     
         19 . The method of  claim 6 , wherein the biological sample is selected from the group consisting of whole blood, plasma, and serum. 
     
     
         20 . The method of  claim 19 , wherein the biological sample is serum. 
     
     
         21 . The method of  claim 8 , wherein said quantifying comprises an assay that utilizes a capture agent. 
     
     
         22 . The method of  claim 21 , wherein said capture agent is selected from the group consisting of and antibody, antibody fragment, nucleic acid-based protein binding reagent, small molecule or variant thereof. 
     
     
         23 . The method of  claim 22 , wherein said assay is selected from the group consisting of enzyme immunoassay (EIA), enzyme-linked immunosorbent assay (ELISA), and radioimmunoassay (RIA). 
     
     
         24 . The method of  claim 6 , further comprising detecting a measurable feature for one or more risk indicia. 
     
     
         25 . A method of determining a probability for recurrence of PDAC in an individual, the method comprising detecting a measurable feature of each of N biomarkers selected from the biomarkers listed in Tables 1 through 4 in a biological sample obtained from said individual, and analyzing said measurable feature to determine the probability for for recurrence of PDAC in said individual. 
     
     
         26 . A method of determining a probability of a positive response to therapy for pancreatic ductal adenocarcinoma (PDAC) in an individual, the method comprising detecting a measurable feature of each of N biomarkers selected from the biomarkers listed in Tables 1 through 4 in a biological sample obtained from said individual, and analyzing said measurable feature to determine the probability of a positive response to therapy for PDAC in said individual. 
     
     
         27 . The method of  claim 26 , wherein said therapy is selected from the group consisting of prophylactic anticoagulants, resection, neoadjuvant chemotherapy and chemoradiation.