US2008064047A1PendingUtilityA1

Methods for diagnosis and prognosis of epithelial cancers

53
Individually held — no corporate assignee on recordPriority: Jan 28, 2005Filed: Jul 27, 2007Published: Mar 13, 2008
Est. expiryJan 28, 2025(expired)· nominal 20-yr term from priority
Inventors:Bruce R. ZetterAdam S. FeldmanW. Scott Mcdougal
G01N 33/57585G01N 33/57557G01N 33/6893G01N 2333/8139
53
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Claims

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.

Claims

exact text as granted — not AI-modified
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  or  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.  
     
     
         4 . A method for facilitating the diagnosis of bladder cancer in a patient comprising: 
 a. obtaining a biological sample from the patient; and    b. detecting the presence or absence of Cystatin B in the biological sample, wherein the presence of Cystatin B epithelial cancer biomarker is indicative of bladder cancer.    
     
     
         5 . A method for diagnosing bladder cancer in a patient comprising: 
 a. measuring the levels of Cystatin B present in a biological sample obtained from the patient, a test sample;    b. comparing the level of Cystatin B in the test sample with the level of Cystatin B epithelial cancer biomarker present in a control sample;    wherein a higher level Cystatin B in the test sample as compared to the level of Cystatin B in the control sample is indicative of bladder cancer.    
     
     
         6 . A method for diagnosing invasive bladder cancer in a patient comprising: 
 a. measuring the levels of Cystatin B present in a biological sample obtained from the patient, a test sample;    b. comparing the level of Cystatin B in the test sample with the level of Cystatin B present in a non-invasive control sample;    wherein a higher level Cystatin B in the test sample as compared to the level of Cystatin B in the non-invasive control sample is indicative of invasive bladder cancer.    
     
     
         7 . The method of  claim 1 ,  2 ,  4 ,  5 , or  6  wherein the biological sample is urine.  
     
     
         8 . The method of  claim 1  or  4  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 according to  claim 8  wherein the antibody-based binding moiety is labeled with a detectable label.  
     
     
         10 . The method according to  claim 9  wherein the label is selected from the group consisting of a radioactive label, a hapten label, a fluorescent label, and an enzymatic label.  
     
     
         11 . The method according to  claim 8  wherein the antibody-based binding moiety is an antibody.  
     
     
         12 . The method according to  claim 11 , wherein the antibody is an monoclonal antibody.  
     
     
         13 . The method of any of claims  2 ,  5  or  6  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.  
     
     
         14 . The method of  claim 13  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.    
     
     
         15 . The method according to  claim 14  wherein the antibody-based binding moiety is labeled with a detectable label.  
     
     
         16 . The method according to  claim 15  wherein the label is selected from the group consisting of a radioactive label, a hapten label, a fluorescent label, and an enzymatic label.  
     
     
         17 . The method according to  claim 14  wherein the antibody-based binding moiety is an antibody.  
     
     
         18 . The method according to  claim 17  wherein the antibody is an monoclonal antibody.  
     
     
         19 . A kit for detecting at least one epithelial cancer biomarker in a urine sample comprising a container for holding a urine sample, and at least one antibody that specifically binds an epithelial cancer biomarker.  
     
     
         20 . The kit of  claim 19  wherein the kit comprises two antibodies that specifically bind to at least one epithelial cancer biomarker, one antibody is immobilized on a solid phase and one antibody is detectably labeled.  
     
     
         21 . A kit for detecting Cystatin B in a urine sample comprising a container for holding a urine sample, and at least one antibody that specifically binds Cystatin B.  
     
     
         22 . The kit of  claim 21  wherein the kit comprises two antibodies that specifically bind to Cystatin B, one antibody is immobilized on a solid phase and one antibody is detectably labeled.  
     
     
         23 . The kit of  claim 19  or  21 , further comprising directions for use.  
     
     
         24 . A method for assessment of a cancer of epithelial origin, the method comprising: 
 (a) assaying for cystatin B in a sample obtained from a subject; and    (b) determining whether cystatin B is present at a level higher than a predetermined level,    thereby indicating whether the subject is at an increased risk of cancer progression.    
     
     
         25 . The method of  claim 24  wherein the sample is selected from the group consisting of a urine, blood, serum, plasma, stool, sputum, cerebrospinal fluid, nipple aspirate, and tissue sample.  
     
     
         26 . The method of  claim 24  wherein the sample is a urine sample.  
     
     
         27 . The method of  claim 24  wherein the cancer of epithelial origin is selected from the group consisting of bladder cancer, breast cancer, basal cell carcinoma, adenocarcinoma, gastrointestinal cancer, lip cancer, mouth cancer, esophageal cancer, small bowel cancer, stomach cancer, colon cancer, liver cancer, pancreas cancer, ovary cancer, cervical cancer, lung cancer, skin cancer, prostate cancer, and renal cell carcinoma.  
     
     
         28 . The method of  claim 24  wherein the cancer of epithelial origin is bladder cancer.  
     
     
         29 . The method of  claim 24  wherein the predetermined level is based on the level of cystatin B normally found in biological samples of healthy subjects.  
     
     
         30 . The method of  claim 24  wherein the predetermined level is based on a prior measurement of the subject's cystatin B level.  
     
     
         31 . The method of  claim 24  wherein the predetermined level is based on the subject's cystatin B level prior to treatment.  
     
     
         32 . The method of  claim 24  wherein the subject's cystatin B level is monitored over time.  
     
     
         33 . The method of  claim 24  wherein the cancer progression is a recurrence of cancer.  
     
     
         34 . The method of  claim 24  wherein the cancer progression is an increase of metastatic activity.  
     
     
         35 . The method of  claim 24  wherein the cancer progression is a progression in cancer grade or stage.  
     
     
         36 . The method of  claim 24  wherein cystatin B protein is assayed.  
     
     
         37 . The method of  claim 36  wherein the cystatin B protein is assayed for by an immunoassay or by mass spectrometry.

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