Methods for diagnosing ovarian cancer

Abstract

The present invention provides protein-based biomarkers and biomarker combinations that are useful in qualifying ovarian cancer status in a patient. In particular, the biomarkers of this invention are useful to classify a subject sample as ovarian cancer, ovarian cancer of low malignant potential, benign ovarian disease or other malignant condition. The biomarkers can be detected by SELDI mass spectrometry, immunoassay, or other means.

1 . A method for qualifying ovarian cancer status in a subject comprising:
 (a) measuring at least one biomarker in a biological sample from the subject, wherein the at least one biomarker is selected from the group consisting of the biomarkers of Table 1; and   (b) correlating the measurement with ovarian cancer status.   
     
     
         2 . The method of  claim 1 , wherein the at least one biomarker is measured by capturing the biomarker on an adsorbent surface of a SELDI probe and detecting the captured biomarkers by laser desorption-ionization mass spectrometry. 
     
     
         3 . The method of  claim 1 , wherein the at least one biomarker is measured by immunoassay. 
     
     
         4 . The method of  claim 1 , wherein the sample is selected from the group consisting of an ovarian cyst fluid sample, a serum sample, or a plasma sample. 
     
     
         5 . The method of  claim 1 , wherein the correlating is performed by a software classification algorithm. 
     
     
         6 . The method of  claim 1 , wherein ovarian cancer status is selected from benign ovarian disease and ovarian cancer of low malignant potential versus ovarian cancer (malignant) and other malignant conditions. 
     
     
         7 . The method of  claim 1 , wherein ovarian cancer status is selected from ovarian cancer of low malignant potential versus benign ovarian disease, ovarian cancer (malignant) and other malignant conditions. 
     
     
         8 . The method of  claim 1 , wherein the ovarian cancer status rules out the possibility of benign ovarian disease. 
     
     
         9 . The method of  claim 1 , wherein the ovarian cancer status rules out the possibility of ovarian cancer (malignant) and other malignant conditions. 
     
     
         10 . The method of  claim 1 , further comprising: (c) managing subject treatment based on the status. 
     
     
         11 . The method of  claim 1 , further comprising: (c) reporting the status to the subject. 
     
     
         12 . The method of  claim 1 , further comprising: (c) recording the status on a tangible medium. 
     
     
         13 . The method of  claim 2 , wherein the adsorbent is a member selected from the group consisting of a hydrophobic adsorbent, an anion exchange adsorbent, a cation exchange adsorbent and a metal chelate adsorbent. 
     
     
         14 . The method of  claim 2 , wherein the adsorbent is a cation exchange adsorbent. 
     
     
         15 . The method of  claim 10 , wherein, if the measurement correlates with ovarian cancer, then managing subject treatment comprises administering a chemotherapeutic agent to the subject. 
     
     
         16 . The method of  claim 10 , further comprising: (d) measuring the at least one biomarker after subject management and correlating the measurement with disease progression. 
     
     
         17 . A method comprising measuring at least one biomarker in a sample from a subject, wherein the at least one biomarker is selected from the group consisting of biomarkers of Table 1. 
     
     
         18 - 24 . (canceled) 
     
     
         25 . A kit comprising:
 (a) a solid support comprising at least one capture reagent attached thereto, wherein the capture reagent binds at least one biomarker from a first group consisting of the biomarkers of Table 1; and   (b) instructions for using the solid support to detect a biomarker of Table 1.   
     
     
         26 . The kit of  claim 25 , wherein the solid support comprising a capture reagent is a SELDI probe. 
     
     
         27 . The kit of  claim 25 , wherein the capture reagent is a hydrophobic adsorbent, an anion exchange adsorbent, a cation exchange adsorbent and a metal chelate adsorbent. 
     
     
         28 . The kit of  claim 25 , additionally comprising: (c) a container containing at least one of the biomarkers of Table 1. 
     
     
         29 . The kit of  claim 25 , additionally comprising: (c) a cation exchange chromatography sorbent. 
     
     
         30 - 38 . (canceled) 
     
     
         40 . A method for qualifying ovarian cancer status in a subject comprising:
 (a) measuring at least one biomarker in a biological sample from the subject, wherein the at least one biomarker is selected from the group consisting of IL-8, IL-18 (6-77) and MCP1; and   (b) correlating the measurement with ovarian cancer status.