Compositions, kits, and methods for identification, assessment, prevention, and therapy of cervical cancer

Abstract

The invention relates to nucleic acid molecules and proteins associated with cervical cancer including pre-malignant conditions such as dysplasia. Compositions, kits, and methods for detecting, characterizing, preventing, and treating human cervical cancers are also provided.

1 . A method of assessing whether a patient is afflicted with cervical cancer or has a pre-malignant condition, the method comprising comparing:
 a) the level of expression of a M722 marker in a patient sample, and   b) the level of expression of the M722 marker in a normal control sample,   wherein a difference between the level of expression of the marker in the patient sample and the normal control sample is an indication that the patient is afflicted with cervical cancer or has a pre-malignant condition.   
     
     
         2 . The method of  claim 1 , wherein the patient has CIN or SIL. 
     
     
         3 . The method of  claim 1 , wherein the sample comprises cells obtained from the patient. 
     
     
         4 . The method of  claim 3 , wherein the sample is a cervical smear. 
     
     
         5 . The method of  claim 3 , wherein the cells are in a fluid selected from the group consisting of a fluid collected by peritoneal rinsing, a fluid collected by uterine rinsing, a uterine fluid, a uterine exudate, a pleural fluid, a cystic fluid, and an cervical exudate. 
     
     
         6 . The method of  claim 1 , wherein the level of expression of the M722 marker in the sample is assessed by detecting the presence in the sample of a protein corresponding to the marker. 
     
     
         7 . The method of  claim 6 , wherein the presence of the protein is detected using a reagent which specifically binds with the protein, wherein the reagent is selected from the group consisting of an antibody and an antigen binding fragment thereof. 
     
     
         8 . The method of  claim 1 , wherein the level of expression of the M722 marker in the sample is assessed by detecting the presence in the sample of a transcribed polynucleotide or portion thereof, wherein the transcribed polynucleotide comprises the M722 marker. 
     
     
         9 . The method of  claim 8 , wherein the transcribed polynucleotide is an mRNA. 
     
     
         10 . The method of  claim 8 , wherein the transcribed polynucleotide is a cDNA. 
     
     
         11 . The method of  claim 8 , wherein the step of detecting further comprises amplifying the transcribed polynucleotide. 
     
     
         12 . The method of  claim 1 , wherein the level of expression of the M722 marker in the sample differs from the level of expression of the M722 marker in the control sample by a factor of at least about 2. 
     
     
         13 . The method of  claim 1 , comprising comparing:
 a) the level of expression in the sample of each of a plurality of markers independently selected from M722 and at least one of the markers listed in Table 1, and   b) the level of expression of each of the plurality of markers in a control sample,   wherein a difference between the level of expression of more than one of the markers in the patient sample as compared to the control sample is an indication that the patient is afflicted with cervical cancer or a pre-malignant condition.   
     
     
         14 . The method of  claim 13 , wherein the plurality comprises at least three of the markers. 
     
     
         15 . The method of  claim 13 , wherein the plurality comprises at least five of the markers. 
     
     
         16 . The method of  claim 1 , wherein the M722 marker is a polypeptide encoded by a nucleic acid molecule comprising a nucleic acid sequence at least 98% identical to SEQ ID NO:25. 
     
     
         17 . The method of  claim 1 , wherein the M722 marker comprises the nucleotide sequence of SEQ ID NO:25. 
     
     
         18 . The method of  claim 1 , wherein the M722 marker is a polypeptide comprising an amino acid sequence which is at least 95% identical to SEQ ID NO:26. 
     
     
         19 . The method of  claim 1 , wherein the M722 marker comprises the amino acid sequence of SEQ ID NO:26. 
     
     
         20 . The method of  claim 1 , wherein the level of expression of the marker in the patient sample is assessed using a technique selected from the group consisting of:
 Northern hybridization, polymerase chain reaction analysis, RT-PCR, probe array and in situ hybridization.   
     
     
         21 . The method of  claim 1 , wherein the level of expression of the marker in the patient sample is assessed using a technique selected from the group consisting of: enzyme immunoassay, radioimmunoassay, Western blot analysis, enzyme linked immuoabsorbant assay (ELISA), immunoprecipitation and immunofluorescence.