Methods for diagnosing cancer

Abstract

The invention provides cDNAs which encodes a signal peptide-containing proteins. It also provides for the use of a cDNA, protein, and antibody in the diagnosis, prognosis, treatment and evaluation of therapies for cancer. The invention further provides vectors and host cells for the production of the protein and transgenic model systems.

1 .- 20 . (canceled) 
     
     
         21 . A method of diagnosing the presence of cancer in a subject by detecting the expression of a signal peptide-containing protein, wherein the method comprises:
 (a) providing a biological sample from the subject;   (b) contacting the biological sample with a polypeptide which specifically binds to antibodies present in the biological sample, wherein the polypeptide is selected from the group consisting of:
 (i) a polypeptide comprising the amino acid sequence of SEQ ID NO:16, and 
 (ii) a polypeptide having an amino acid sequence at least about 90% identical to the amino acid sequence of SEQ ID NO:16, 
   (c) detecting the presence of bound polypeptide in the biological sample;   (d) comparing the presence of bound polypeptide in the biological sample with the presence of bound polypeptide in a control sample;   (e) wherein a higher presence in the biological sample as compared to the control sample is correlated with the presence of cancer.   
     
     
         22 . The method of  claim 21 , wherein the subject is a human. 
     
     
         23 . The method of  claim 21 , wherein the biological sample comprises body fluids, tissues, or extracts of such tissues. 
     
     
         24 . The method of  claim 21 , wherein the polypeptide is labeled. 
     
     
         25 . The method of  claim 24 , wherein the label is a visible or radioactive label. 
     
     
         26 . The method of  claim 24 , wherein the label is selected from the group consisting of anthocyanins, green fluorescent protein (OFP), 6 glucuronidase. luciferase, Cy3, and Cy5, radioactive forms of hydrogen, radioactive forms of iodine, radioactive forms of phosphorous, and radioactive forms of sulfur. 
     
     
         27 . The method of  claim 21 , wherein differences between the polypeptide encoding the signal peptide-containing protein and SEQ ID NO:16 comprise conservative amino acid substitutions. 
     
     
         28 . The method of  claim 21 , wherein the signal peptide-containing protein has:
 (a) a G protein coupled receptor signature at S 125 GMQFLACISIDRYVAV;   (b) three potential N-glycosylation sites at N 6 , N 19 , and N 276 ;   (c) a potential glycosaminoglycan attachment site at S 148 ; and   (d) ten potential phosphorylation sites at S 25 , T 74 , T 177 , S 195 , T 223 , Y 269 , S 278 , S 309 , S 323 , and S 330 ; or   (e) any combination thereof.   
     
     
         29 . The method of  claim 21 , wherein the cancer is selected from the group consisting of adenocarcinomas, prostate cancer, breast cancer, renal cell cancer, stomach cancer, testicular seminoma, mucinous cystadenoma of the ovary, transitional cell carcinoma of the bladder, uterine adenosquamous carcinoma 
     
     
         30 . The method of  claim 29 , wherein the cancer is breast cancer. 
     
     
         31 . The method of  claim 30 , wherein the breast cancer is ductal or lobular. 
     
     
         32 . The method of  claim 21 , wherein the tissue sample is from a prostrate of the subject, and a higher presence of bound polypeptide in the biological sample is indicative of the presence of adenofibromatous hyperplasia in the subject, which is a prognostic of prostate cancer. 
     
     
         33 . A method of diagnosing the presence of cancer in a subject by detecting the expression of a signal peptide-containing protein, wherein the method comprises:
 (a) providing a biological sample from the subject;   (b) contacting the biological sample with an antibody which specifically binds to a signal peptide-containing protein present in the biological sample, wherein the antibody specifically binds to a polypeptide selected from the group consisting of:
 (i) a polypeptide comprising the amino acid sequence of SEQ ID NO:16, and 
 (ii) a polypeptide having an amino acid sequence at least about 90% identical to the amino acid sequence of SEQ ID NO:16, 
   (c) detecting the presence of bound antibody in the biological sample;   (d) comparing the presence of bound antibody in the biological sample with the presence of bound antibody in a control sample;   (e) wherein a higher presence in the biological sample as compared to the control sample is correlated with the presence of cancer.   
     
     
         34 . The method of  claim 33 , wherein the antibody is polyclonal or monoclonal. 
     
     
         35 . The method of  claim 33 , wherein the antibody is labeled. 
     
     
         36 . A method of diagnosing the presence of cancer in a subject by detecting the expression of a signal peptide-containing protein, wherein the method comprises:
 (a) providing a biological sample from the subject;   (b) contacting the biological sample with a nucleic acid probe at least 18 nucleic acids in length and having at least 50% sequence identity with the sequence of SEQ ID NO: 17;   (c) detecting the presence of a hybridization complex in the biological sample;   (d) comparing the presence of hybridization complex in the biological sample with the presence of hybridization complex in a control sample;   (e) wherein a higher amount of hybridization complex in the biological sample is correlated with cancer.   
     
     
         37 . The method of  claim 36 , wherein the subject is a human. 
     
     
         38 . The method of  claim 36 , wherein the nucleic acid is labeled. 
     
     
         39 . The method of  claim 36 , wherein the hybridization technique is selected from the group consisting of membrane hybridization and polymer coated slide hybridization. 
     
     
         40 . The method of  claim 36 , wherein the nucleic acid is selected from the group consisting of:
 (a) a nucleic acid having the sequence shown in  FIG. 1A  from A 24  to G 44 ;   (b) a nucleic acid having the sequence shown in  FIG. 1A  from G 159  to C 182 ;   (c) a nucleic acid having the sequence shown in  FIG. 1B  from G 561  to A 596 ;   (d) a nucleic acid having the sequence shown in  FIG. 1D  from A 1011  to T 1046 ;   (e) a nucleic acid having the sequence as shown in any one of SEQ ID Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21, 23, 24, 25, 27, 28, 29, 30, 32, 33, 34, 36, 37, 38, 39, 40, 42, 43, 45, 46, 47, 48, 50, 51, 52, 54, 55, 56, 58, 59, 61, 62, 63, 66, 67, 70, 71, 77, 78; and   (f) a nucleic acid having at least 50% sequence identity to a sequence as shown in any one of SEQ ID Nos. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21, 23, 24, 25, 27, 28, 29, 30, 32, 33, 34, 36, 37, 38, 39, 40, 42, 43, 45, 46, 47, 48, 50, 51, 52, 54, 55, 56, 58, 59, 61, 62, 63, 66, 67, 70, 71, 77, 78.