Biomarker for ovarian cancer CTAP3-related proteins

Abstract

The present invention provides a protein-based biomarker that is useful in qualifying ovarian cancer status in a patient. In particular, the biomarker of this invention is useful to classify a subject sample as ovarian cancer or non-ovarian cancer. The biomarker can be detected by SELDI mass spectrometry.

1 . A method for qualifying ovarian cancer status in a subject comprising:
 (a) measuring at least one biomarker including a CTAP3-related protein in a biological sample from the subject; and   (b) correlating the measurement with ovarian cancer status.   
     
     
         2 . The method of  claim 1 , wherein the CTAP3-related protein is CTAP3 (residues 44-128 of SEQ ID NO:1). 
     
     
         3 . The method of  claim 2  wherein CTAP3 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. 
     
     
         4 . The method of  claim 2  wherein CTAP3 is measured by immunoassay. 
     
     
         5 . The method of  claim 2  wherein the sample is serum. 
     
     
         6 . The method of  claim 2  wherein the correlating is performed by a software classification algorithm. 
     
     
         7 . The method of  claim 2  wherein ovarian cancer status is selected from ovarian cancer and non-ovarian cancer. 
     
     
         8 . The method of  claim 2  wherein ovarian cancer status is selected from early stage and late stage 2. 
     
     
         9 . The method of  claim 2 , further comprising: (c) reporting the status to the subject. 
     
     
         10 . The method of  claim 2 , further comprising: (c) recording the status on a tangible medium. 
     
     
         11 . The method of  claim 2 , further comprising: (c) managing subject treatment based on the status. 
     
     
         12 . The method of  claim 11 , further comprising: (d) measuring CTAP3 after managing treatment and correlating the measurement with disease progression. 
     
     
         13 . The method of  claim 3 , wherein the adsorbent is an IMAC copper adsorbent or a biospecific adsorbent. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 2 , further comprising measuring and correlating at least one biomarker selected from the group consisting of CA125, transferrin, haptoglobin, ApoA1, transthyretin, ITIH4 internal fragment, beta 2-microglobulin, hepcidin, prostatin, osteopontin, esoinophil-derived neurotoxin, leptin, prolactin, IGF-II, hemoglobin and modified forms thereof. 
     
     
         16 . The method of  claim 2 , further comprising measuring and correlating at least one biomarker selected from the group consisting of CA125 II, CA15-3, CA19-9, CA72-4, CA 195, tumor associated trypsin inhibitor (TATI), CEA, placental alkaline phosphatase (PLAP), Sialyl TN, galactosyltransferase, macrophage colony stimulating factor (M-CSF, CSF-1), lysophosphatidic acid (LPA), 110 kD component of the extracellular domain of the epidermal growth factor receptor (p110EGFR), tissue kallikreins, e.g., kallikrein 6 and kallikrein 10 (NES-1), prostasin, HE4, creatine kinase B (CKB), LASA, HER-2/neu, urinary gonadotropin peptide, Dianon NB 70/K, Tissue peptide antigen (TPA), SMRP, osteopontin, and haptoglobin, leptin, prolactin, insulin-like growth factor I and insulin-like growth factor II. 
     
     
         17 . A method for determining the course of ovarian cancer comprising:
 (a) measuring, at a first time, at least one biomarker including a CTAP3-related protein in a biological sample from the subject;   (b) measuring, at a second time, the CTAP3-related protein in a biological sample from the subject; and   (c) comparing the first measurement and the second measurement; wherein the comparative measurements determine the course of the ovarian cancer.   
     
     
         18 . The method of  claim 17 , wherein the CTAP3-related protein is CTAP3 (amino acid residues 44-128 of SEQ ID NO:1). 
     
     
         19 . A kit comprising:
 (a) a solid support comprising at least one capture reagent attached thereto, wherein the capture reagent binds to a CTAP3-related protein; and   (b) instructions for using the solid support to detect the CTAP3-related protein.   
     
     
         20 . The kit of  claim 19 , wherein the CTAP3-related protein is CTAP3 (amino acid residues 44-128 of SEQ ID NO:1). 
     
     
         21 . The kit of  claim 19 , wherein the solid support comprising a capture reagent is a SELDI probe. 
     
     
         22 .- 35 . (canceled)