Methods for diagnosis and prognosis of cancer

Abstract

We have discovered a protein in humans, herein referred to as collagen like gene (CLG) product (SEQ ID NOS: 12 and 13), that is expressed in human prostate cancer and breast cancer cell lines but not in normal adult, placenta, lung, liver, skeletal muscle, kidney or pancreas tissues. We have also discovered that the level of CLG mRNA expression correlates positively with the metastatic potential of the cancer cell lines tested.

1 . A method for detecting the presence of CLG in a biological sample comprising contacting the biological sample with an agent capable of detecting CLG polypeptide or mRNA such that the presence of CLG is detected in the biological sample. 
     
     
         2 . The method of  claim 1 , wherein the biological sample is a tissue sample, or isolate thereof. 
     
     
         3 . The method of  claim 2 , wherein the tissue sample is derived from the pancreas, stomach, liver, secretory gland, bladder, lung, skin, prostate gland, ovary, cervix, uterus, brain, eye, connective tissue, bone, muscles or vasculature. 
     
     
         4 - 15 . (canceled) 
     
     
         16 . A kit for detecting the presence of CLG in a biological sample, or isolate thereof, comprising a labeled or labelable agent capable of detecting CLG polypeptide or mRNA in a biological sample. 
     
     
         17 . The kit of  claim 16 , further comprising a means for determining the amount of CLG in the sample. 
     
     
         18 - 21 . (canceled) 
     
     
         22 . A method of diagnosing cancer in a patient, comprising:
 (a) obtaining a biological sample; and   (b) measuring levels of CLG in said sample, wherein levels of CLG in said sample greater than a baseline level is indicative of cancer.   
     
     
         23 . The method of  claim 22 , wherein the biological sample is selected from blood, tissue, serum, stool, urine, sputum, cerebrospinal fluid and supernatant from cell lysate. 
     
     
         24 . (canceled) 
     
     
         25 . A method for prognosing cancer in an individual having cancer comprising:
 (a) obtaining a biological sample from said individual;   (b) measuring CLG amounts to obtain a CLG level in said sample;   (c) correlating said CLG level with a baseline level; and   (d) correlating levels of CLG greater than the baseline with an indication of unfavorable prognosis and levels of CLG at the baseline or less with a favorable prognosis.   
     
     
         26 . The method of  claim 25 , wherein the biological sample is selected from blood, tissue, serum, stool, urine, sputum, cerebrospinal fluid and supernatant from cell lysate. 
     
     
         27 . (canceled) 
     
     
         28 . A method for determining the metastatic potential of a tumor comprising measuring the level of CLG expression in said tumor, wherein levels of CLG in said tumor greater than a base line level indicates an increased metastatic potential. 
     
     
         29 - 34 . (canceled) 
     
     
         35 . An isolated polynucleotide encoding a CLG protein comprising the amino acid sequence as set forth in SEQ ID NOS: 2, 4 or 13. 
     
     
         36 . An isolated polynucleotide encoding a polypeptide comprising a peptide having amino acid sequence of SEQ ID NOS: 2, 4 or 13. 
     
     
         37 - 39 . (canceled) 
     
     
         40 . An isolated polynucleotide having the nucleotide sequence of SEQ ID NOS: 1 or 3 or the complement thereto or a unique fragment thereof. 
     
     
         41 . An isolated polynucleotide encoding CLG having the nucleotide sequence of nucleotides 1-1511 of SEQ ID NO: 1, or nucleotides 1-1215 of SEQ ID NO: 3, or nucleotides 1826-2733 of SEQ ID NO: 3, or nucleotides 1-1375 of SEQ ID NO. 12 or the complement thereto. 
     
     
         42 . A recombinant vector containing the polynucleotide of  claims 35 - 41 . 
     
     
         43 . A host cell containing the vector of  claim 42 . 
     
     
         44 - 46 . (canceled) 
     
     
         47 . An isolated antibody or antibody fragment which selectively binds a CLG having amino acid sequence of SEQ ID NOS: 2, 4 or 13. 
     
     
         48 - 51 . (canceled) 
     
     
         52 . A method for inhibiting CLG expression in a cell comprising administering to the cell an effective amount of a compound that inhibits CLG expression or activity. 
     
     
         53 . The method of  claim 52 , wherein said compound is selected from the group consisting of antibodies, aptemers, RNAi and antisense nucleic acid. 
     
     
         54 - 55 . (canceled) 
     
     
         56 . An isolated nucleic acid, the nucleic acid being at least 15 nucleotides in length and hybridizes under stringent condition to a nucleic acid comprising the sequence of nucleotides 1-1511 SEQ ID NO: 1 or nucleotides 1-1375 of SEQ ID NO: 12.