Methods for diagnosis and prognosis of epithelial cancers

Abstract

The present invention is based on the discovery that three proteins, Cystatin B, Chaperonin 10, and Profilin are present in the urine of patients with bladder cancer, a cancer of epithelial origin. Accordingly, the present invention is directed to methods for prognostic evaluation of cancers of epithelial origin and to methods for facilitating diagnosis of cancers of epithelial origin by monitoring the presence of these markers in biological samples. The invention is also directed to markers for therapeutic efficacy.

1 . A method for facilitating the diagnosis of a patient for a cancer of epithelial origin comprising:
 a. obtaining a biological sample from the patient; and   b. detecting the presence or absence of at least one epithelial cancer biomarker in the biological sample,   wherein the presence of at least one epithelial cancer biomarker is indicative of cancer of epithelial origin, and wherein the epithelial cancer biomarker is selected from the group consisting of Cystatin B, Chaperonin 10, and Profilin.   
     
     
         2 . A method for diagnosing a cancer of epithelial origin in a patient comprising:
 a. measuring at least one epithelial cancer biomarker levels present in a biological sample obtained from the patient, a test sample;   b. comparing the level of at least one epithelial cancer biomarker in the test sample with the level of epithelial cancer biomarker present in a control sample;   wherein a higher level of at least one epithelial cancer biomarker in the test sample as compared to the level of epithelial cancer biomarker in the control sample is indicative of cancer of epithelial origin, and wherein the epithelial cancer biomarker is selected from the group consisting of Cystatin B, Chaperonin 10, and Profilin.   
     
     
         3 . The method of  claim 1 , 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, ovary cancer, cervical cancer, lung cancer, skin cancer, prostate cancer, and renal cell carcinoma. 
     
     
         4 - 6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the biological sample is urine. 
     
     
         8 . The method of  claim 1 , wherein the presence or absence of at least
 one epithelial cancer biomarker or Cystatin B is detected using an antibody-based binding moiety which specifically binds to at least one epithelial cancer biomarker or to Cystatin B.   
     
     
         9 . The method of  claim 2 , wherein the level of at least one
 epithelial cancer biomarker or Cystatin B is measured by measuring the protein level of at least one epithelial cancer biomarker protein or Cystatin B.   
     
     
         10 . The method of  claim 9 , wherein the protein level of epithelial cancer biomarker or level of Cystatin B 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 the epithelial cancer biomarker or to Cystatin B to form an antibody-epithelial cancer biomarker complex; and   b. detecting the presence of the complex, thereby measuring the level of epithelial cancer biomarker present.   
     
     
         11 . The method according to  claim 8 , wherein the antibody-based binding moiety is labeled with a detectable label. 
     
     
         12 . The method according to  claim 11 , wherein the label is selected from the group consisting of a radioactive label, a hapten label, a fluorescent label, and an enzymatic label. 
     
     
         13 . The method according to  claim 8 , wherein the antibody-based binding moiety is an antibody. 
     
     
         14 . The method according to  claim 13 , wherein the antibody is an monoclonal antibody. 
     
     
         15 - 19 . (canceled) 
     
     
         20 . The method of  claim 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, ovary cancer, cervical cancer, lung cancer, skin cancer, prostate cancer, and renal cell carcinoma. 
     
     
         21 . The method according to  claim 10 , wherein the antibody-based binding moiety is labeled with a detectable label. 
     
     
         22 . The method according to  claim 10 , wherein the antibody-based binding moiety is an antibody.