Diagnosis of Gynecological Neoplasms By Detecting The Levels of Oviduct-Specific Glycoprotein

Abstract

The present invention provides a method for detecting cancer in a patient. A sample from the patient is provided, and the level of oviduct-specific glycoprotein (OGP) in the sample is determined and compared to a control sample. Increased levels of OGP in the sample as compared to the control indicates that the patient has cancer. In one aspect, the cancer is a gynecological cancer, such as ovarian cancer. Kits for conducting the methods of the invention are also provided.

1 . A method of detecting a gynecological cancer in a patient comprising:
 (a) providing a sample from the patient;   (b) determining the level of oviduct specific glycoprotein (OGP) in the sample; and   (c) comparing the level of OGP in the sample to a control sample, wherein increased levels of OGP as compared to the control indicates that the patient has a gynecological cancer.   
     
     
         2 . A method according to  claim 1  for monitoring the progression of a gynecological cancer in a patient comprising:
 (a) providing a sample from a patient;   (b) determining the level of OGP in the sample;   (c) repeating steps (a) and (b) at a later point in time and comparing the result of step (b) with the result of step (c) wherein a difference in the level of OGP is indicative of the progression of the gynecological cancer in the patient.   
     
     
         3 . A method according to  claim 1  for determining whether or not a gynecological cancer is benign in a patient comprising:
 (a) providing a sample from the patient;   (b) detecting the level of OGP in the sample; and   (c) comparing the level of OGP in the sample to a control sample, wherein increased levels of OGP as compared to the control indicates that the gynecological cancer is benign.   
     
     
         4 . A method according to  claim 1  for distinguishing between noninvasive and invasive gynecological cancers, comprising:
 (a) providing a sample from a patient;   (b) determining the level of OGP expression in the sample; and   (c) comparing the level of OGP in the sample to a control sample, wherein increased levels of OGP in the sample from a patient as compared to the control indicates that the gynecological cancer is noninvasive.   
     
     
         5 . (canceled) 
     
     
         6 . A method according to  claim 1  wherein the cancer is ovarian cancer. 
     
     
         7 . A method according to  claim 6  wherein the cancer is early stage ovarian adenocarcinoma. 
     
     
         8 . A method according to  claim 1  wherein the cancer is an ovarian neoplasm. 
     
     
         9 . A method according to  claim 8  wherein the ovarian neoplasm is undergoing Mullerian epithelial differentiation. 
     
     
         10 . A method according to  claim 1  wherein the level of nucleic acid molecules encoding OGP are determined in step (b). 
     
     
         11 . A method according to  claim 10  wherein the level of expression of OGP mRNA is determined. 
     
     
         12 . A method according to  claim 1  wherein the level of the OGP protein is determined in step (b). 
     
     
         13 . A method according to  claim 12  wherein an antibody is used to determine the levels of the OGP protein. 
     
     
         14 . A method according to  claim 1  wherein the sample is gynecological tissue, serum, ascites or blood. 
     
     
         15 . A kit for detecting a gynecological cancer in a patient comprising (i) reagents for conducting a method according to  claim 1  and (ii) instructions for its use. 
     
     
         16 . (canceled) 
     
     
         17 . A kit according to  claim 15  wherein the reagents comprise antibodies specific to the OGP protein. 
     
     
         18 . A kit for monitoring the progression of a gynecological cancer in a patient comprising (i) reagents for conducting a method according to  claim 2  and (ii) instructions for its use. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . A kit for determining whether or not a gynecological cancer is benign in a patient comprising (i) reagents for conducting a method according to  claim 3  and (ii) instructions for its use. 
     
     
         22 - 23 . (canceled) 
     
     
         24 . A kit for distinguishing between noninvasive and invasive gynecological cancers comprising (i) reagents for conducting a method according to  claim 4  and (ii) instructions for its use. 
     
     
         25 - 26 . (canceled)