Serum Markers Associated With Early and Other Stages of Breast Cancer

Temple University
posted on 08/05/2011

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This invention features methods for diagnosing early stage breast cancer, particularly Stage 0 and Stage I breast cancer. Generally, the methods comprise obtaining a biological sample comprising a plurality of serum albumin complexes from a subject, separating the serum albumin complexes on a membrane using two-dimensional membrane electrophoresis to obtain a separation profile, and comparing, for example, with a computer configured to compare profiles, the separation profile with reference profiles for a healthy subject and/or a subject with early stage breast cancer. The comparison of the separation profile with one or more reference profiles indicates whether the subject has early stage breast cancer. The methods can further comprise treating the subject with a therapy suitable for treating breast cancer, including therapies specific for Stage 0 or Stage I breast cancer, and including therapies for any stage of breast cancer.

• Development of ELISA-type diagnostic kits for detection of early stage breast cancer (Stage 0 and Stage I). These kits are particularly suitable for women with dense breasts that are likely to be missed by mammography, for young women who do not have access to mammography, and for high-risk women needing an interval screening between annual mammography.

• The Albumin complexes can be separated on a membrane by any means suitable in the art, including polyacrylamide gel electrophoresis followed by transfer to the membrane.
• Membranes can be either hydrophobic or hydrophilic, and preferably have a low charge or a net neutral charge.