Compositions and methods for monitoring breast cancer treatment

Abstract

The present invention provides compositions and processes for preparing the same wherein the compositions are useful for monitoring breast cancer treatment.

1 . An isolated and purified human protein characterized in that:
 (a) the protein has a molecular weight of about 9.29 kDa; and   (b) increases in concentration in the serum of a woman afflicted with breast cancer during treatment by oral administration of glutamine and radiation therapy.   
     
     
         2 . The isolated and purified protein of  claim 1 , wherein the protein upon digestion by trypsin generates a fragment with a molecular weight of about 1581 daltons and/or a fragment with a molecular weight of about 1709 daltons. 
     
     
         3 . An isolated and purified protein fraction from serum of a human prepared by a process comprising:
 (a) administering glutamine to the human; and   (b) fractionating serum proteins from the human to isolate a protein fraction of about 9.29 kDa molecular weight.   
     
     
         4 . The isolated and purified protein fraction of  claim 3 , wherein the process further comprises isolating serum proteins from the human prior to the fractionating step. 
     
     
         5 . The isolated and purified protein fraction of  claim 3 , wherein the fractionating comprises adhering the serum proteins to a solid substrate, desorbing the proteins from the solid substrate, and separated by Surface Enhanced Laser Desorption Ionization-Mass Spectrometry. 
     
     
         6 . The isolated and purified protein fraction of  claim 3 , wherein the fractionating comprises performing size exclusion chromatography. 
     
     
         7 . The isolated and purified protein fraction of  claim 3 , wherein the human is a woman afflicted with breast cancer and is treated with radiation therapy while being administered glutamine. 
     
     
         8 . The protein fraction of  claim 3 , wherein a fragment is generated upon digestion with trypsin. 
     
     
         9 . The protein fraction of  claim 8 , wherein the fragment generated has a molecular weight of about 1581 daltons and/or a fragment with a molecular weight of about 1709 daltons. 
     
     
         10 . A method of monitoring the effectiveness of glutamine supplementation to protect breast tissue against radiation injury, the method comprising:
 monitoring the concentration of a 9.29 kDa protein in serum of a human afflicted with breast cancer, before, during, and after the administration of glutamine and radiation therapy.   
     
     
         11 . The method of  claim 10 , wherein the 9.29 kDa protein upon digestion by trypsin generates a fragment with a molecular weight of about 1581 daltons and/or a fragment with a molecular weight of about 1709 daltons. 
     
     
         12 . The method of  claim 10 , wherein the monitoring comprises:
 adhering serum proteins of the human to a solid substrate and desorbing and fractionating the proteins from the solid substrate by Surface Enhanced Laser Desorption Ionization-Mass Spectrometry.   
     
     
         13 . A method of monitoring a response to glutamine administration comprising:
 monitoring the concentration of a 9.29 kDa protein in serum of a human before, during, and after glutamine administration.   
     
     
         14 . An isolated and purified protein from serum of a human prepared by
 (a) administering glutamine to the human;   (b) isolating serum proteins from the human;   (c) fractionating the serum proteins to isolate a protein of about 9.29 kDa molecular weight, wherein the protein upon digestion with trypsin generates a fragment with a molecular weight of about 1581 daltons and/or a fragment with a molecular weight of about 1709 daltons.