Method for the early diagnosis of carcinomas

Abstract

The present invention relates to a method for the early diagnosis of carcinomas and their preliminary stages, which comprises determining the overexpression of a cell cycle regulatory protein in a body sample. The invention also provides a kit usable for this purpose.

What is claimed is:  
     
         1 . A method for early diagnosing carcinomas and their preliminary stages, comprising determining the overexpression of a cell cycle regulatory protein in a body sample, wherein the cell cycle regulatory protein is a cyclin-dependent kinase inhibitor.  
     
     
         2 . The method according to  claim 1 , wherein the carcinomas are those of the upper respiratory tract.  
     
     
         3 . The method according to  claim 1 , wherein the carcinomas are anogenital carcinomas.  
     
     
         4 . The method according to  claim 3 , wherein the anogenital carcinoma is a cervical carcinoma.  
     
     
         5 . The method according to  claim 1 , wherein the cyclin-dependent kinase inhibitor is a protein p14, p15, p16, p18, p19, p21 or p27.  
     
     
         6 . The method according to  claim 1 , wherein the body sample is blood, smears, sputum, urine, bone marrow, organ punctates, biopsies, or lymph.  
     
     
         7 . The method according to  claim 1 , wherein the overexpression is determined by detecting the nucleic acid encoding the cell cycle regulatory protein.  
     
     
         8 . The method according to  claim 1 , wherein the overexpression is determined by detecting the cell cycle regulatory protein.  
     
     
         9 . The method according to claim B, comprising reacting an antibody directed against a cell cycle regulatory protein with the body sample.  
     
     
         10 . A kit for carrying out the method according to  claim 1 , comprising: 
 (a) a first reagent for detecting the expression of cyclin-dependent kinase inhibitor, which is selected from the group consisting of a nucleic acid hybridrizing to a cyclin-dependent kinase inhibitor and an antibody directed against a cyclin-dependent kinase inhibitor; and    (b) a second reagent for performing a control reaction, which is selected from the group consisting of a nucleic acid encoding a cyclin-dependent kinase inhibitor, a cyclin-dependent kinase inhibitor, a sample of cells expressing a cyclin-dependent kinase inhibitor, and a preparaton of fixed cells in a suspension or on a side being positive for a cyclin-dependent kinase inhibitor.    
     
     
         11 . The kit according to  claim 10 , further comprising auxiliary reagents selected form the group consisting of secondary antibodies, reagents for performing a reporter reaction, buffers and stains.