Biomarkers for Head-and-Neck Cancers and Precancers

Abstract

The invention provides markers and methods for detecting head-and-neck precancers, (including OPLs), cancers and related disease conditions in a subject. The invention also provides localization and imaging methods for head-and-neck precancers (including OPLs) and cancers, along with kits for carrying out methods of the invention. The invention further provides therapeutic applications for head-and-neck precancers (including OPLs) and cancers which employ head-and-neck precancer and cancer markers, polynucleotides encoding the markers, and binding agents for the markers.

What is claimed is: 
     
         1 . A method for detecting a head-and-neck disease in a subject, the method comprising comparing:
 (a) levels of one or more OPL or head-and-neck cancer markers listed in Table 5 that are extracted from a sample from the subject; and   (b) normal levels of expression of the OPL or head-and-neck cancer markers in a control sample,   wherein a significant difference in levels of OPL or head-and-neck cancer markers, relative to the corresponding normal levels, is indicative of head-and-neck disease.   
     
     
         2 . A method according to  claim 1 , comprising:
 (a) contacting a biological sample obtained from a subject with one or more binding agent that specifically binds to the OPL or head-and-neck cancer markers or parts thereof; and   (b) detecting in the sample amounts of OPL or head-and-neck cancer markers that bind to the binding agents, relative to a predetermined standard or cut-off value, and thereby determining the presence or absence of the head-and-neck disease in the subject.   
     
     
         3 . A method according to  claim 2 , wherein the binding agent is an antibody. 
     
     
         4 . A method according to  claim 1 , wherein detection of a level of OPL or head- and-neck cancer markers that is significantly higher compared to the standard is indicative of OPL or head-and-neck cancer. 
     
     
         5 . A method according to  claim 1 , wherein detection of a level of OPL or head- and-neck cancer markers that is significantly lower compared to the standard is indicative of OPL or head-and-neck cancer. 
     
     
         6 . A method according to  claim 1 , wherein the sample is obtained from tissues, extracts, cell cultures, cell lysates, lavage fluid, or physiological fluids. 
     
     
         7 . A method according to  claim 6 , wherein the sample is obtained from an OPL or tumor tissue. 
     
     
         8 . A method of  claim 1 , wherein the one or more OPL or head-and-neck cancer markers comprises one or more of YWHAZ, S100A7, hnRNPK and stratifin. 
     
     
         9 . A method for assessing the aggressiveness or indolence of OPL or head-and-neck cancer, comprising comparing:
 (a) levels of expression of one or more OPL or head-and-neck cancer markers or polynucleotides encoding the markers listed in Table 1 and Table 6 in a subject sample; and   (b) normal levels of expression of the OPL or head-and-neck cancer markers or polynucleotides encoding the markers, in a control sample, wherein a significant difference between the levels in the subject sample and normal levels is an indication that the OPL or cancer is aggressive or indolent.   
     
     
         10 . A method according to  claim 9 , comprising:
 (a) contacting a biological sample obtained from a subject with one or more binding agent that specifically binds to the OPL or head-and-neck cancer markers or parts thereof; and   (b) detecting in the sample amounts of OPL or head-and-neck cancer markers that bind to the binding agents, relative to a predetermined standard or cut-off value, and thereby determining the presence or absence of the head-and-neck disease in the subject.   
     
     
         11 . A method according to  claim 10 , wherein the binding agent is an antibody. 
     
     
         12 . A method according to  claim 9 , wherein detection of a level of OPL or head- and-neck cancer markers that is significantly higher compared to the standard is indicative of OPL or head-and-neck cancer. 
     
     
         13 . A method according to  claim 9 , wherein detection of a level of OPL or head- and-neck cancer markers that is significantly lower compared to the standard is indicative of OPL or head-and-neck cancer. 
     
     
         14 . A method according to  claim 9 , wherein the sample is obtained from tissues, extracts, cell cultures, cell lysates, lavage fluid, or physiological fluids. 
     
     
         15 . A method according to  claim 7 , wherein the sample is obtained from an OPL or tumor tissue. 
     
     
         16 . The method of  claim 9 , wherein the one or more OPL or head-and-neck cancer markers or polynucleotides encoding the marker comprises one or more of YWHAZ, S100A7, hnRNPK and stratifin. 
     
     
         17 . A diagnostic composition or kit comprising
 (a) an agent that binds to an OPL or head-and-neck cancer marker listed in Table 5 or hybridizes to a polynucleotide encoding such marker; or   (b) a set of OPL or head-and-neck cancer markers, comprising a plurality of polypeptides comprising or consisting of at least 2, 3, 4, 5, or 6 of the markers listed in Table 5 or Table 2 or Table 6.   
     
     
         18 . A diagnostic composition or kit according to  claim 17 , wherein the polypeptides comprise one or more of YWHAZ, S100A7, and stratifin. 
     
     
         19 . A diagnostic composition or kit according to  claim 17 , wherein the polypeptides comprise one or more of YWHAZ, hnRNPK and stratifin. 
     
     
         20 . A diagnostic composition or kit according to  claim 17 , wherein the binding agent comprises a detectable substance or binds directly or indirectly to a detectable substance.