Endometrial Phase or Endometrial Cancer Biomarkers

Abstract

Methods for detecting endometrial diseases or an endometrium phase in a subject are described comprising measuring endometrial markers or polynucleotides encoding the markers in a sample from the subject. The invention also provides localization or imaging methods for endometrial diseases, and kits for carrying out the methods of the invention. The invention also contemplates therapeutic applications for endometrial diseases employing endometrial markers, polynucleotides encoding the markers, and/or binding agents for the markers.

1 - 41 . (canceled) 
     
     
         42 . A method for diagnosing an endometrial disease or an endometrial phase in a mammalian subject by detecting one or more endometrial markers, or polynucleotides encoding the one or more endometrial markers, associated with an endometrial disease, the method comprising:
 (a) measuring in a biological sample obtained from the subject an amount of one or more endometrial markers of Table 1, or polynucleotides encoding the one or more markers; and   (b) comparing the measured amount of one or more endometrial markers or polynucleotides encoding the one or more markers with a standard amount, wherein a difference between the detected amount and the standard amount is indicative of the presence of endometrial disease or of the endometrium phase.   
     
     
         43 . The method of  claim 42 , wherein the standard amount is an amount of the marker or the polynucleotide measured in non-disease tissue and wherein a higher measured amount relative to the standard amount is indicative of endometrial disease in the biological sample. 
     
     
         44 . The method of  claim 42 , wherein the endometrial disease is endometrial cancer. 
     
     
         45 . The method according to  claim 42  wherein the biological sample is obtained from tissues, extracts, cell cultures, cell lysates, lavage fluid, or physiological fluids of the mammalian subject. 
     
     
         46 . The method according to  claim 45  wherein the sample is obtained from a tumor tissue. 
     
     
         47 . The method of  claim 42 , further comprising monitoring endometrial cancer, monitoring metastasis of endometrial cancer, or assessing aggressiveness or indolence of endometrial cancer, wherein one or more of steps (a) and (b) are repeated at multiple points in time. 
     
     
         48 . The method of  claim 42  further comprising:
 (c) contacting the biological sample with at least one binding anent that specifically binds to the one or more endometrial markers or parts thereof; and 
 (d) measuring the amounts of the one or more endometrial markers that bind to the binding agent, and comparing the measure amount of the bound marker with a standard amount, wherein a difference between the detected amount of bound marker and the standard amount is indicative of the presence of endometrial disease or of the endometrium phase. 
 
     
     
         49 . The method of  claim 48  wherein the one or more binding agents is an antibody. 
     
     
         50 . The method of  claim 48 , wherein the standard amount is an amount of the marker or the polynucleotide measured in non-disease tissue and wherein a higher measured amount relative to the standard amount is indicative of endometrial disease in the biological sample. 
     
     
         51 . The method of  claim 48 , wherein the endometrial disease is endometrial cancer. 
     
     
         52 . The method according to  claim 48  wherein the biological sample is obtained from tissues, extracts, cell cultures, cell lysates, lavage fluid, or physiological fluids of the mammalian subject. 
     
     
         53 . The method according to  claim 52  wherein the sample is obtained from a tumor tissue. 
     
     
         54 . The method of  claim 48 , further comprising monitoring endometrial cancer, monitoring metastasis of endometrial cancer, or assessing aggressiveness or indolence of endometrial cancer, wherein one or more of steps (a) and (b) are repeated at multiple points in time. 
     
     
         55 . A method according to  claim 42  wherein the polynucleotide detected is mRNA. 
     
     
         56 . A method according to  claim 55  wherein the polynucleotide is detected by
 (a) contacting the biological sample with at least one oligonucleotide that hybridizes to the polynucleotide; and 
 (b) measuring in the sample the amount of nucleic acids that hybridize to the polynucleotides relative to the amount of a standard, wherein a difference between the detected amount and the standard amount is indicative of the presence of endometrial disease or of the endometrium phase. 
 
     
     
         57 . The method of  claim 46  wherein the mRNA is detected using an amplification reaction. 
     
     
         58 . A method according to  claim 55  wherein the mRNA is detected using a hybridization technique employing oligonucleotide probes that hybridize to the polynucleotides or complements of such polynucleotides. 
     
     
         59 . A kit for determining the presence of an endometrial disease in a subject, comprising a known amount of one or more binding agent that specifically binds to one or more endometrial marker listed in Table 1, wherein the binding agent comprises a detectable substance, or it binds directly or indirectly to a detectable substance. 
     
     
         60 . A kit for determining the presence of an endometrial disease in a subject, comprising a known amount of one or more oligonucleotides that specifically hybridize to polynucleotides encoding one or more endometrial marker listed in Table 1, wherein the oligonucleotide is directly or indirectly labeled with a detectable substance.