Methods and kits for predicting prognosis of cancer using soluble mortalin in blood

Abstract

Provided are methods of determining a presence or level of soluble mortalin in a body fluid of a subject, and predicting prognosis of a subject diagnosed with cancer (e.g., solid tumor) by determining the presence or level of soluble mortalin in a body fluid of the subject. Also provided are kits for determining presence and/or level of soluble mortalin in a body fluid of the subject and/or predicting prognosis of a subject diagnosed with cancer, comprising at least two distinct antibodies to mortalin directed against different epitopes of said mortalin.

What is claimed is: 
     
         1 . A method of determining a presence or level of soluble mortalin in a biological fluid sample, the method comprising:
 (a) contacting a biological fluid sample with an anti-mortalin antibody under conditions which allow immunocomplex formation; and   (b) determining a presence or level of said immunocomplex,   thereby determining said presence or said level of the soluble mortalin in the biological fluid sample.   
     
     
         2 . The method of  claim 1 , wherein said anti-mortalin antibody is bound to a solid support. 
     
     
         3 . The method of  claim 2 , wherein a presence or level of said immunocomplex is determined by surface plasmon resonance. 
     
     
         4 . The method of  claim 2 , wherein a presence or level of said immunocomplex is determined by Enzyme-linked immunosorbent assay (ELISA). 
     
     
         5 . The method of  claim 1 , wherein said soluble mortalin is not attached to a cell, to a cell membrane, or to a cell organelle. 
     
     
         6 . The method of  claim 1 , wherein said biological fluid sample is selected from the group consisting of blood, urine, tear, saliva, stool, cerebrospinal fluid, synovial fluid, lymph fluids, external secretions of a respiratory tract, external secretions of an intestinal tract external secretions of a genitourinary tract, milk, amniotic fluid and chorionic villi. 
     
     
         7 . The method of  claim 6 , wherein said biological fluid sample is a blood sample. 
     
     
         8 . The method of  claim 7 , wherein said blood sample is serum or plasma. 
     
     
         9 . The method of  claim 1 , further comprising:
 (a) determining the level of soluble heat shock protein 70 (sHSP70) in said biological fluid sample.   
     
     
         10 . A kit for determining presence and/or level of soluble mortalin in a biological fluid sample comprising: at least two distinct antibodies to mortalin directed against different epitopes of said mortalin. 
     
     
         11 . The kit of  claim 10 , further comprising a secondary antibody for binding one of said at least two antibodies. 
     
     
         12 . The kit of  claim 10 , further comprising an Enzyme-linked immunosorbent assay (ELISA) plate. 
     
     
         13 . The kit of  claim 12 , further comprising an anti-soluble heat shock protein 70 (sHSP70) antibody. 
     
     
         14 . The kit of  claim 10 , wherein said biological fluid sample is a body fluid sample selected from the group consisting of blood, urine, tear, saliva, stool, cerebrospinal fluid, synovial fluid, lymph fluids, external secretions of a respiratory tract, external secretions of an intestinal tract external secretions of a genitourinary tract, milk, amniotic fluid and chorionic villi. 
     
     
         15 . The kit of  claim 14 , wherein said biological fluid sample is serum. 
     
     
         16 . The kit of  claim 10 , wherein one antibody of said at least two antibodies is a mouse monoclonal against human mortalin, and, optionally wherein one antibody of said at least two antibodies is a goat polyclonal against human mortalin. 
     
     
         17 . The kit of  claim 16 , wherein said mouse monoclonal antibody against human mortalin is attached to a solid support. 
     
     
         18 . The kit of  claim 10 , further comprising a calibration standard for mortalin levels. 
     
     
         19 . A composition of matter comprising a body fluid and antibodies to mortalin. 
     
     
         20 . The composition of matter of  claim 19 , wherein said antibodies comprise both monoclonal and polyclonal antibodies to mortalin. 
     
     
         21 . The composition of matter of  claim 20 , wherein one antibody of said antibodies is a mouse monoclonal against human mortalin, and, optionally wherein one antibody of said at least two antibodies is a goat polyclonal against human mortalin, optionally, wherein said mouse monoclonal antibody against human mortalin is attached to a solid support. 
     
     
         22 . The composition of matter of  claim 20 , further comprising a secondary antibody for binding one of said antibodies. 
     
     
         23 . The composition of matter of  claim 19 , wherein said antibodies and said mortalin are comprised in an immune complex. 
     
     
         24 . The composition of matter of  claim 19 , further comprising an anti-soluble heat shock protein 70 (sHSP70) antibody. 
     
     
         25 . The composition of matter of  claim 19 , wherein said biological fluid sample is a body fluid sample selected from the group consisting of blood, urine, tear, saliva, stool, cerebrospinal fluid, synovial fluid, lymph fluids, external secretions of a respiratory tract, external secretions of an intestinal tract external secretions of a genitourinary tract, milk, amniotic fluid and chorionic villi, optionally, 
       wherein said biological fluid sample is serum.