Biomarker for ovarian cancer

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.  
     
     
         14 . The method of  claim 3 , wherein the adsorbent is a biospecific adsorbent.  
     
     
         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 . The kit of  claim 19 , wherein the capture reagent is an IMAC copper adsorbent.  
     
     
         23 . The kit of  claim 19 , additionally comprising: (c) a container containing the CTAP3 biomarker.  
     
     
         24 . The kit of  claim 19 , additionally comprising: (c) an immunospecific chromatography sorbent.  
     
     
         25 . A kit comprising: 
 (a) a solid support comprising at least one capture reagent attached thereto, wherein the capture reagents binds a CTAP3-related protein; and    (b) a container containing the CTAP3-related protein.    
     
     
         26 . The kit of  claim 25 , wherein the CTAP3-related protein is CTAP3 (amino acid residues 44-128 of SEQ ID NO:1).  
     
     
         27 . The kit of  claim 26 , wherein the capture reagent is an IMAC capture reagent or a biospecific capture reagent.  
     
     
         28 . A software product comprising: 
 (a) code that accesses data attributed to a sample, the data comprising measurement of at least one biomarker including a CTAP3-related protein in the sample; and    (b) code that executes a classification algorithm that classifies the ovarian cancer status of the sample as a function of the measurement.    
     
     
         29 . A method comprising communicating to a subject a diagnosis relating to ovarian cancer status determined from the correlation of 3 a CTAP3-related protein in a sample from the subject.  
     
     
         30 . The method of  claim 29 , wherein the diagnosis is communicated to the subject via a computer-generated medium.  
     
     
         31 . A method for identifying a compound that interacts with a CTAP3-related protein, wherein said method comprises: 
 a) contacting the CTAP3-related protein with a test compound; and    b) determining whether the test compound interacts with the CTAP3-related protein.    
     
     
         32 . The method of  claim 31 , wherein the CTAP3-related protein is CTAP3 (amino acid residues 44-128 of SEQ ID NO:1).  
     
     
         33 . A method for modulating the concentration of a CTAP3-related protein in a cell, wherein said method comprises: 
 a) contacting said cell with a small molecule which inhibits the expression of the CTAP3-related protein.    
     
     
         34 . The method of  claim 33 , wherein the CTAP3-related protein is CTAP3 (amino acid residues 44-128 of SEQ ID NO:1).  
     
     
         35 . A method of treating ovarian cancer in a subject, wherein said method comprises: 
 administering to a subject a therapeutically effective amount of a small molecule, wherein said small molecule inhibits expression of CTAP3.