Compositions and methods for detecting pancreatic cancer

Abstract

Provided herein are methods of detecting pancreatic cancer in a subject, the method comprising measuring in a sample from the subject a level of CA19-9 polysaccharide relative to a reference, and a level of a polynucleotide or polypeptide of at least one marker selected from the group consisting of: OPN, MIA, CEACAM-1, MIC-1, SPON1, HSP27, POSTN, and LGALS3BP relative to a reference, wherein an increased level of the CA19-9 polysaccharide relative to a reference and an increased level of the polynucleotide or polypeptide relative to a reference indicates presence of pancreatic cancer in the subject.

1 . A method of detecting pancreatic cancer in a subject, the method comprising measuring in a sample from the subject
 a level of CA19-9 polysaccharide relative to a reference, and   a level of a polynucleotide or polypeptide of at least one marker selected from the group comprising: OPN, MIA, CEACAM-1, MIC-1, SPON1, HSP27, POSTN, LGALS3BP, or a combination thereof relative to a reference,   wherein an increased level of said CA19-9 polysaccharide relative to a reference and an increased level of said polynucleotide or polypeptide relative to a reference indicates presence of pancreatic cancer in the subject.   
     
     
         2 . A method of distinguishing a pancreatic ductal adenocarcinoma (PDAC) from a benign pancreatic condition, the method comprising measuring in a sample from the subject
 a level of CA19-9 polysaccharide relative to a reference, and   a level of a polynucleotide or polypeptide of at least one marker selected from the group comprising: OPN, MIA, CEACAM-1, MIC-1, SPON1, HSP27, POSTN, LGALS3BP, or a combination thereof relative to a reference.   
     
     
         3 . A method of selecting a subject for pancreatic cancer treatment, the method comprising detecting in a sample from the subject
 an increased level of CA19-9 polysaccharide relative to a reference, and   an increased level of a polynucleotide or polypeptide of at least one marker selected from the group comprising: OPN, MIA, CEACAM-1, MIC-1, SPON1, HSP27, POSTN, LGALS3BP, or a combination thereof relative to a reference.   
     
     
         4 . A method of characterizing pancreatic cancer status in a subject, the method comprising measuring in a sample from the subject
 a level of CA19-9 polysaccharide relative to a reference, and   a level of a polynucleotide or polypeptide of at least one marker selected from the group comprising: OPN, MIA, CEACAM-1, MIC-1, SPON1, HSP27, POSTN, LGALS3BP, or a combination thereof relative to a reference,   wherein an increased level of said CA19-9 polysaccharide relative to a reference and an increased level of said polynucleotide or polypeptide relative to a reference indicates presence of pancreatic cancer in the subject.   
     
     
         5 . The method of  claim 1 , wherein said at least one marker is selected from the group comprising: MIA, SPON1, MIC-1, and CEACAM-1. 
     
     
         6 . The method of any of  claim 1 , wherein the measuring step comprises measuring in a sample from the subject levels of markers comprising a CA19-9 polysaccharide, a HSP27 polynucleotide or polypeptide, and a MIA polynucleotide or polypeptide. 
     
     
         7 . The method of any of  claim 1 , wherein the measuring step comprises measuring in a sample from the subject levels of markers comprising a CA19-9 polysaccharide, a CEACAM-1 polynucleotide or polypeptide, a MIC-1 polynucleotide or polypeptide, a SPON1 polynucleotide or polypeptide, and a MIA polynucleotide or polypeptide. 
     
     
         8 . A method of detecting pancreatic cancer and/or characterizing a pancreatic cancer status in a subject, the method comprising measuring in a serum sample from the subject levels of markers comprising
 a CA19-9 polysaccharide, a HSP27 polypeptide, and a MIA polypeptide,   using a multiplexed bead based immunoassay, wherein levels of each marker are measured relative to a reference, and wherein increased levels of said markers indicate presence of pancreatic cancer.   
     
     
         9 . A method of detecting pancreatic cancer and/or characterizing a pancreatic cancer status in a subject, the method comprising measuring in a serum sample from the subject levels of markers comprising
 a CA19-9 polysaccharide, a CEACAM-1 polypeptide, a MIC-1 polypeptide, a SPON1 polypeptide, and a MIA polypeptide,   using a multiplexed bead based immunoassay, wherein levels of each marker are measured relative to a reference, and wherein increased levels of said markers indicate presence of pancreatic cancer.   
     
     
         10 . A method of detecting pancreatic cancer and/or characterizing a pancreatic cancer status in a subject, the method comprising measuring in a serum sample from the subject levels of markers comprising
 a CA19-9 polysaccharide and a MIA polypeptide   using a multiplexed bead based immunoassay, wherein levels of each marker are measured relative to a reference, and wherein increased levels of said markers indicate presence of pancreatic cancer.   
     
     
         11 . A method of detecting pancreatic cancer and/or characterizing a pancreatic cancer status in a subject, the method comprising measuring in a serum sample from the subject levels of markers comprising
 a CA19-9 polysaccharide and a MIC-1 polypeptide   using a multiplexed bead based immunoassay, wherein levels of each marker are measured relative to a reference, and wherein increased levels of said markers indicate presence of pancreatic cancer.   
     
     
         12 . A method of detecting pancreatic cancer and/or characterizing a pancreatic cancer status in a subject, the method comprising measuring in a serum sample from the subject levels of markers comprising
 a CA19-9 polysaccharide and a CEACAM-1 polypeptide   using a multiplexed bead based immunoassay, wherein levels of each marker are measured relative to a reference, and wherein increased levels of said markers indicate presence of pancreatic cancer.   
     
     
         13 . A method of detecting pancreatic cancer and/or characterizing a pancreatic cancer status in a subject, the method comprising measuring in a serum sample from the subject levels of markers comprising
 a CA19-9 polysaccharide and a SPON1 polypeptide   using a multiplexed bead based immunoassay, wherein levels of each marker are measured relative to a reference, and wherein increased levels of said markers indicate presence of pancreatic cancer.   
     
     
         14 . The method of  claim 1 , wherein the sample is a serum sample. 
     
     
         15 . The method of  claim 1 , wherein the level of polysaccharide or polypeptide is measured using a bead based immunoassay or an ELISA. 
     
     
         16 . The method of  claim 4 , wherein the pancreatic cancer status is non-pancreatic cancer, pancreatitis, intraductal papillary mucinous neoplasm (IPMN), early stage pancreatic ductal adenocarcinoma (PDAC), or late stage pancreatic ductal adenocarcinoma (PDAC). 
     
     
         17 . The method of  claim 2 , wherein the benign pancreatic condition is pancreatitis or intraductal papillary mucinous neoplasm (IPMN). 
     
     
         18 . The method of  claim 3 , wherein the pancreatic cancer treatment is chemotherapy or surgery. 
     
     
         19 . The method of  claim 1 , wherein the subject is a human. 
     
     
         20 . A diagnostic composition comprising a capture reagent detecting a CA19-9 polysaccharide and a capture reagent detecting at least one marker selected from the group comprising:
 a MIA polynucleotide or polypeptide,   a MIC-1 polynucleotide or polypeptide,   a CEACAM-1 polynucleotide or polypeptide,   a OPN polynucleotide or polypeptide,   a SPON1 polynucleotide or polypeptide,   a HSP27 polynucleotide or polypeptide,   a POSTN polynucleotide or polypeptide,   a LGALS3BP polynucleotide or polypeptide, or a combination thereof.   
     
     
         21 . The method of  claim 20 , wherein the capture reagent detecting a CA19-9 polysaccharide is an anti-CA19-9 antibody or an antigen-binding fragment thereof. 
     
     
         22 . The method of  claim 20 , wherein the capture reagents are fixed to a substrate. 
     
     
         23 . The method of  claim 22 , wherein the substrate is a magnetic bead. 
     
     
         24 . The diagnostic composition of  claim 20 , comprising an anti-CA19-9 antibody or an antigen-binding fragment thereof, and at least one antibody or antigen-binding fragment thereof selected from the group consisting of: an anti-MIC-1 antibody, an anti-CEACAM-1 antibody, an anti-MIA antibody, and an anti-SPON1 antibody. 
     
     
         25 . The diagnostic composition of  claim 20 , comprising an anti-CA19-9 antibody or an antigen-binding fragment thereof, an anti-HSP27 antibody or an antigen-binding fragment thereof, and an anti-MIA antibody or an antigen-binding fragment thereof. 
     
     
         26 . The diagnostic composition of  claim 20 , comprising an anti-CA19-9 antibody or an antigen-binding fragment thereof, an anti-CEACAM-1 antibody or an antigen-binding fragment thereof, an anti-MIC-1 antibody or an antigen-binding fragment thereof, an anti-SPON1 antibody or an antigen-binding fragment thereof, and an anti-MIA antibody or an antigen-binding fragment thereof. 
     
     
         27 . A kit comprising the diagnostic composition of  claim 20 . 
     
     
         28 . (canceled)