Cyr61 as a biomarker for diagnosis and prognosis of cancers of epithelial origin

Abstract

Urinary Cyr61 protein levels are up regulated in patients that have cancers of epithelial origin, i.e. breast cancer and ovarian cancer. Accordingly, the present invention is directed to methods for prognostic evaluation, and diagnosis of cancers of epithelial origin. Further, the amount of Cyr61 protein detected in a urine sample correlates with disease status such that Cyr61 levels can be used to predict the presence of, as well as the metastatic potential of cancer. Thus, measuring the level of Cyr61 in urine provides a quick, easy, and safe screen that can be used to both diagnose and prognose cancer in a patient.

1 . A method for facilitating the diagnosis of a subject for a cancer of epithelial origin comprising:
 a. measuring Cyr61 levels present in a test urine sample obtained from the subject;   b. comparing the level of Cyr61 in the test urine sample with the level of Cyr61 present in a control urine sample;   
       wherein a higher level of Cyr61 in the test sample as compared to the level of Cyr61 in the control sample is indicative of cancer of epithelial origin. 
     
     
         2 . A method for prognostic evaluation of a subject suspected of having or having, cancer of epithelial origin comprising:
 a. measuring the level of Cyr61 present in a test urine sample obtained from the subject to obtain a first sample;   b. comparing the level determined in step (a) to a level of Cyr61 in a urine sample obtained from the same subject at a later time point; and   c. evaluating the prognosis of said patient based on the comparison of step (b), wherein a higher level of Cyr61 in the urine sample obtained from the same subject at a later time point indicates progression to a more aggressive form of cancer.   
     
     
         3 . The method of any of  claims 1 - 2 , wherein the cancer of epithelial origin is selected from the group consisting of breast cancer, basal cell carcinoma, adenocarcinoma, gastrointestinal cancer, lip cancer, mouth cancer, esophageal cancer, small bowel cancer, stomach cancer, colon cancer, liver cancer, bladder cancer, pancreas cancer, ovarian cancer, cervical cancer, lung cancer, skin cancer, prostate cancer, and renal cell carcinoma. 
     
     
         4 . The method of any of  claims 1 - 2 , wherein the level of Cyr61 protein is measured by a method comprising the steps of:
 a. contacting the test sample, or preparation thereof, with an antibody-based binding moiety which specifically binds Cyr61 to form an antibody-Cyr61 complex; and   b. detecting the presence of the complex, thereby measuring the level of Cyr61 present.   
     
     
         5 . The method according to  claim 4 , wherein the antibody-based binding moiety is labeled with a detectable label. 
     
     
         6 . The method according to  claim 5 , wherein the label is selected from the group consisting of a radioactive label, a hapten label, a fluorescent label, and an enzymatic label. 
     
     
         7 . The method according to  claim 4 , wherein the antibody-based binding moiety is an antibody. 
     
     
         8 . The method according to  claim 7 , wherein the antibody is an monoclonal antibody. 
     
     
         9 . A kit for detecting Cyr61 in a urine sample comprising a container for holding a urine sample, and at least one antibody that specifically binds Cyr61. 
     
     
         10 . The kit of  claim 9 , wherein the kit comprises two antibodies that specifically bind to Cyr61, one antibody is immobilized on a solid phase and one antibody is detectably labeled. 
     
     
         11 . The kit of  claim 9 , further comprising directions for use. 
     
     
         12 . A method to direct treatment of a subject which comprises having a subject tested for the levels of Cyr61 in a urine sample obtained from the subject, wherein a clinician reviews the results and if the subject's urine sample has a higher level of Cyr61 than the level of Cyr61 in the control sample, the clinician directs the subject to be treated for cancer of epithelial origin.