Methods for the Detection of Circulating Tumor Cells

Abstract

The present invention provides methods for revealing, detecting, and analyzing circulating tumor cells in the blood of a subject. Revealing detectable circulating tumor cells allows for early stage detection and diagnosis in addition to long term prognosis in subjects with cancer. Additionally, enrichment allows for robust detection and clinically meaningful analysis of low volume samples for use in clinical settings as well as innovative methods for the treatment of cancers.

What is claimed is: 
     
         1 . A method for determining responsiveness of a subject to a therapeutic regime comprising revealing circulating tumor cells of the subject comprising:
 a) removing or degrading proteins, cells, or a combination thereof, in physical association with the surface of the circulating tumor cell, thereby unmasking and revealing the circulating tumor cells, and   b) analyzing the revealed circulating tumor cells, thereby determining the responsiveness of the subject to a therapeutic regime.   
     
     
         2 . A method for determining a candidate subject for a clinical trial comprising revealing circulating tumor cells of the subject comprising:
 a) removing or degrading proteins, cells, or a combination thereof, in physical association with the surface of the circulating tumor cell, thereby unmasking and revealing the circulating tumor cells, and   b) analyzing the revealed circulating tumor cells, thereby determining a candidate subject for a clinical trial.   
     
     
         3 . A method for determining effectiveness of a candidate agent in the treatment of cancer comprising revealing circulating tumor cells of a subject being administered the candidate agent comprising:
 a) removing or degrading proteins, cells, or a combination thereof, in physical association with the surface of the circulating tumor cell, thereby unmasking and revealing the circulating tumor cells, and   b) analyzing the revealed circulating tumor cells, thereby determining the effectiveness of the candidate agent in the treatment of cancer.