Method for detecting risk of progression of low grade cervical dysplasia

Abstract

The invention provides methods for identifying conditions of low grade cervical dysplasia and assessing the progressive potential of individual lesions to develop into high grade cervical dysplasia and cervical squamous cell cancer as well as cervical adenocarcinoma.

1 - 16 . (canceled) 
     
     
         17 . A kit for assessing a change in a patient condition of low grade cervical dysplasia to a condition of high grade cervical dysplasia comprising a probe for detecting a genomic amplification of chromosome 3q and instructions for using the probe to assess the change in a patient condition of low grade cervical dysplasia to a condition of high grade cervical dysplasia in accordance with a method of any of claims  1 - 16 . 
     
     
         18 . A method for identifying a patient at risk of developing invasive cervical carcinoma, comprising:
 making a first identification of a genomic amplification of chromosome 3q in a sample obtained from a patient known to have had a condition of either   
       i) low grade cervical dysplasia; or 
       ii) no dysplasia 
       thereby identifying a patient at risk of developing invasive cervical carcinoma. 
     
     
         19 . The method of  claim 18 , wherein the genomic amplification is within the 3q26 locus of chromosome 3q. 
     
     
         20 . The method of  claim 18 , wherein the low grade cervical dysplasia is a cervical intraepithelial neoplasm of grade 1. 
     
     
         21 . The method of  claim 18 , wherein a cytologically normal pap smear is obtained from a patient having no dysplasia. 
     
     
         22 . The method of  claim 19 , wherein the genomic amplification is detected by hybridizing the sample to a probe comprising a detectable marker and a nucleic acid sequence that is complimentary to a nucleic acid sequence of the 3q26 locus. 
     
     
         23 . The method of  claim 22 , wherein the nucleic acid sequence of the probe is complimentary to the telomerase gene, or a portion thereof. 
     
     
         24 . The method of  claim 23 , wherein the detectable marker emits a fluorescent signal. 
     
     
         25 . The method of  claim 23  wherein the detectable marker is chromogenic. 
     
     
         26 . The method of  claim 22 , further comprising hybridizing the sample to a centromere enumeration probe comprising a detectable marker and a nucleic acid sequence that is complimentary to a nucleic acid sequence proximate to the centromere of chromosome 3. 
     
     
         27 . The method of  claim 19 , wherein the genomic amplification is detected by Polymerase Chain Reaction. 
     
     
         28 . The method of  claim 19 , wherein the genomic amplification is detected by measuring the amount of the telomerase polypeptide. 
     
     
         29 - 63 . (canceled) 
     
     
         64 . The method of  claim 22 , wherein the nucleic acid sequence of the probe is complimentary a nucleic acid sequence selected from the group consisting of ectopic viral integration site 1, myelodysplasia syndrome 1, myoneurin, G protein-coupled receptor 160, protein kinase C, SKI-like, claudin 11, eukaryotic translation initiation factor 5A2, traf2 and nck interacting kinase, phospholipase D1, growth hormone secretagogue receptor, tumor necrosis factor 10, epithelial cell transforming sequence 2 oncogene, p53 target zinc finger protein, phosphoinositide-3-kinase, mitofusin 1 and ubiquitin specific protease 13. 
     
     
         65 - 67 . (canceled) 
     
     
         68 . A method of diagnosing adenocarcinoma in a subject comprising:
 detecting genomic amplification of a telomerase gene or portion thereof in a subject.   
     
     
         69 . The method of  claim 68 , wherein the genomic amplification is detected by hybridizing the sample to a probe comprising a detectable marker and a nucleic acid sequence that is complimentary to a nucleic acid sequence of the 3q26 locus. 
     
     
         70 . The method of  claim 69 , wherein the probe comprises a contig of four overlapping BAC clones. 
     
     
         71 . The method of  claim 68 , wherein the nucleic acid sequence of the probe is complimentary to the telomerase gene, or a portion thereof. 
     
     
         72 . The method of  claim 68 , wherein the sample is a preparation from the cervix. 
     
     
         73 . The method of  claim 68 , further comprising hybridizing the sample to a centromere enumeration probe comprising a detectable marker and a nucleic acid sequence that is complimentary to a nucleic acid sequence proximate to the centromere of chromosome 3. 
     
     
         74 . The method of  claim 68 , further comprising hybridizing the sample to a centromere enumeration probe comprising a detectable marker and a nucleic acid sequence that is complimentary to a nucleic acid sequence proximate to the centromere of chromosome 7. 
     
     
         75 - 76 . (canceled)