Biomaker for ovarian and endometrial cancer: hepcidin

Abstract

The present invention provides protein-based biomarkers and biomarker combinations that are useful in qualifying ovarian cancer status as well as endometrical cancer status in a patient. In particular, it has been found that hepcidin is a biomarker for both ovarian cancer and endometrial cancer and that a panel of biomarkers, including hepcidin, transthyretin and optionally other markers are useful to classify a subject sample as ovarian cancer or non-ovarian cancer. The biomarkers can be detected by SELDI mass spectrometry.

1 . A method for qualifying ovarian cancer status in a subject comprising:
 (a) measuring one or more biomarkers in a biological sample from the subject, wherein at least one biomarker is hepcidin; and   (b) correlating the measurement or measurements with an ovarian cancer status selected from ovarian cancer and non-ovarian cancer.   
     
     
         2 . The method of  claim 1 , comprising measuring a plurality of biomarkers in the biological sample, wherein the plurality of biomarkers further comprises transthyretin. 
     
     
         3 . The method of  claim 2 , wherein the plurality of biomarkers further comprises at least one biomarker selected from the group consisting of: Apo A1, transferrin, CTAP-III and ITIH4 fragment. 
     
     
         4 . The method of  claim 3 , wherein the plurality of biomarkers further comprises at least two biomarkers selected from the group consisting of: Apo A1, transferrin, CTAP-III and ITIH4 fragment. 
     
     
         5 . The method of  claim 3 , wherein the plurality of biomarkers further comprises at least three biomarkers selected from the group consisting of: Apo A1, transferrin, CTAP-III and ITIH4 fragment. 
     
     
         6 . The method of  claim 3 , wherein the plurality of biomarkers further comprises Apo A1, transferrin, CTAP-III and ITIH4 fragment. 
     
     
         7 . The method of  claim 3 , wherein hepcidin is hepcidin-25, transthyretin is cysteinylated transthyretin, and ITIH4 fragment is ITIH4 fragment 1. 
     
     
         8 . The method of  claim 3 , wherein the plurality of biomarkers further comprises β-2 microglobulin. 
     
     
         9 .- 10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein the at least one biomarker is measured by immunoassay. 
     
     
         12 . The method of any of  claim 1 , wherein the sample is blood or a blood derivative, ovarian cyst fluid, ascites, or urine. 
     
     
         13 .- 17 . (canceled) 
     
     
         18 . The method of  claim 1 , wherein non-ovarian cancer is a gynecological condition selected from benign ovarian cyst, endometriosis, uterine fibroma, breast cancer and cervical cancer. 
     
     
         19 .- 26 . (canceled) 
     
     
         27 . A kit comprising:
 (a) a solid support comprising at least one capture reagent attached thereto, wherein the capture reagent binds hepcidin; and   (b) instructions for using the solid support to detect hepcidin.   
     
     
         28 .- 29 . (canceled) 
     
     
         30 . A kit comprising:
 (a) at least one solid support comprising at least one capture reagent attached thereto, wherein the capture reagent binds or reagents bind hepcidin and transthyretin; and   (b) instructions for using the solid support or supports to detect hepcidin and transthyretin.   
     
     
         31 .- 43 . (canceled)