Methods and materials for the diagnosis and treatment of sporadic basal cell carcinoma

Abstract

Methods for detection of the onset or presence of sporadic basal cell carcinoma in an animal by measuring for elevated levels of extopic expression of Gli1 in the animal's epidermal tissue sample suspected of harboring sporadic basal cell carcinoma.

What is claimed is:  
     
         1 . A method for the detection of the onset or presence of sporadic basal cell carcinoma (BCC) in an animal, which comprises measuring the presence and level of expression of Gli 1.  
     
     
         2 . The method of  claim 1 , wherein the expression of said Gli1 is ectopic expression.  
     
     
         3 . The method of  claim 1 , wherein said expression is measured by collecting a biological sample from said animal suspected of harboring a basal cell carcinoma; and culturing said sample with/treating a of frog embryos for a period of time sufficient for the development on said frog embryos of skin tumors; 
 wherein the formation/development of said skin tumors is indicative of the presence of said basal cell carcinoma.    
     
     
         4 . An assay for the detection of the onset or presence of sporadic basal cell carcinoma (BCC) in an animal, comprising an observable test colony which exhibits the demonstrable development of neoplasia upon contact with ectopically expressed Gli1 from a biological sample taken from an animal; other reagents; and directions for use thereof.  
     
     
         5 . A method of testing the ability of a drug or other entity to modulate the activity of Gli1 which comprises: 
 A. culturing test cells which demontrate a tumorous condition and which contain elevated levels of Gli1;    B. adding the drug under test; and    C. measuring the change if any, in the tumorous condition of said test cells.    
     
     
         6 . An assay system for screening drugs and other agents for ability to modulate the expression of Gli in epidermal cells, comprising: 
 A. culturing observable test cells inoculated with a drug or agent directed to Gli1;    B. harvesting a supernatant from said test cells; and    C. examining said supernatant for the presence of a tumorous mass from sporadic basal cell carcinoma, wherein an increase or a decrease in the size of the tumorous mass indicates the ability of a drug to modulate the expression or activity of said Gli1.    
     
     
         7 . A test kit for the demonstration of basal cell carcinoma in a eukaryotic cellular sample, comprising: 
 A. a predetermined amount of a detectably labelled specific binding partner to Gli1;    B. other reagents; and    C. directions for use of said kit.    
     
     
         8 . A method of preventing and/or treating cellular debilitations, derangements and/or dysfunctions and/or other disease states in mammals caused by the development and presence of sporadic basal cell carcinoma, comprising administering to a mammal a therapeutically effective amount of a material selected from the group consisting of inhibitors of the expression and activity of Gli1, their complements or fragments thereof, and mixtures thereof, or a specific binding partner thereto.  
     
     
         9 . A pharmaceutical composition for the treatment of cellular debilitations, derangements and/or dysfunctions and/or other disease states in mammals caused by the development and presence of sporadic basal cell carcinoma, comprising a therapeutically effective amount of a material selected from the group consisting of inhibitors of the expression and activity of Gli1, their complements or fragments thereof, and mixtures thereof, or a specific binding partner thereto; and a pharmaceutically acceptable carrier therefor.