Systems and methods for breast cancer detection and risk assessment

Abstract

The invention relates to a simple screening test for neoplasia, a precancerous condition, or cancer of the breast. A method is described whereby a breast cancer marker is detected in breast fluid. In a particular embodiment, the method involves treating samples of breast fluids with an aldehyde detecting reagent without any prewashing. The appearance in breast fluids of a marker that is detected by an aldehyde detecting reagent, such as a Schiff's reagent, correlates very well with the disease status of the breast cancer subjects from which the fluids were obtained. Screening test kits are also provided.

1 . A method of screening a patient for breast cancer or for elevated breast cancer risk, comprising:
 providing a solid support configured to receive a volume of breast aspirate fluid from the patient;   wherein the volume of breast aspirate fluid is obtained from a breast duct of a patient;   wherein the volume of breast aspirate fluid is obtained at least in part by the application of suction within or along the breast of the patient;   wherein the solid support comprises an aldehyde detecting agent; and   detecting a change in a detectable property produced by contacting the volume of breast aspirate fluid to the aldehyde detecting reagent on the solid support;   wherein the volume of breast aspirate fluid does not undergo pretreatment or modification before being placed on the solid support.   
     
     
         2 . The method of  claim 1 , wherein the solid support comprises a pad. 
     
     
         3 . The method of  claim 1 , wherein the detectable property comprises at least one of:
 color, spectral properties, spectral absorption, fluorescence, chemi-luminescence, mass spectral properties or chromatographic properties.   
     
     
         4 . The method of  claim 1 , wherein the aldehyde detecting reagent comprises Schiff's reagent. 
     
     
         5 . The method of  claim 1 , wherein the aldehyde marker comprises low molecular weight aldehydes that are soluble in water. 
     
     
         6 . The method of  claim 1 , wherein the volume of breast aspirate fluid is additionally screened for the presence of at least one additional marker of breast cancer. 
     
     
         7 . The method of  claim 6 , wherein the solid support comprises the at least one additional marker. 
     
     
         8 . The method of  claim 1 , wherein the solid support comprises a water-insoluble substrate. 
     
     
         9 . The method of  claim 1 , wherein a shape of the solid support is generally a tube, test plate, well, beads, disc or sphere. 
     
     
         10 . A method for monitoring the effectiveness of a chemotherapy treatment of a patient with breast cancer, comprising:
 treating a sample of breast fluid secreted from a nipple of a patient undergoing chemotherapy with an aldehyde-detecting reagent;   detecting a change in a detectable property produced by treating the sample of breast fluid with the aldehyde-detecting reagent;   wherein the detectable property comprises one or more of: color, spectral properties, spectral absorption, fluorescence, chemi-luminescence, mass spectral properties or chromatographic properties; and   wherein the sample of breast fluid is treated directly with the aldehyde-detecting reagent, such that the breast fluid does not undergo pretreatment or modification prior to contacting the aldehyde-detecting reagent.   
     
     
         11 . The method of  claim 10 , wherein a significant reduction in the detectable property compared to a control is indicative that a chemotherapy treatment is generally effective. 
     
     
         12 . The method of  claim 10 , wherein the aldehyde-detecting reagent is positioned on a solid support. 
     
     
         13 . The method of  claim 12 , wherein the solid support comprises a pad. 
     
     
         14 . The method of  claim 10 , wherein the aldehyde detecting reagent comprises Schiff s reagent. 
     
     
         15 . The method of  claim 10 , wherein the breast fluid is additionally screened for the presence of at least one additional marker of breast cancer. 
     
     
         16 . A solid support for screening a patient for breast cancer or for elevated breast cancer risk, said solid support comprising:
 a solid support having at least one portion configured to receive a volume of breast aspirate fluid of a patient;   wherein the volume of breast aspirate fluid is obtained from a breast duct of a patient;   wherein the volume of breast aspirate fluid is obtained at least in part by the application of suction within or along the breast of the patient;   wherein the solid support comprises an aldehyde detecting agent;   wherein a change in a detectable property produced by contacting the volume of breast aspirate fluid to the aldehyde detecting reagent on the solid support is generally indicative of a presence of cancer or an elevated risk of breast cancer;   wherein the solid support is configured to directly receive the volume of breast aspirate fluid thereon; and   wherein the solid support comprises a pad or a disc.   
     
     
         17 . The solid support of  claim 16 , wherein the detectable property comprises at least one of: color, spectral properties, spectral absorption, fluorescence, chemi-luminescence, mass spectral properties or chromatographic properties. 
     
     
         18 . The solid support of  claim 16 , wherein the solid support comprises the at least one additional marker. 
     
     
         19 . The solid support of  claim 16 , wherein the solid support comprises a water-insoluble substrate. 
     
     
         20 . The solid support of  claim 16 , wherein a shape of the solid support is generally a tube, test plate, well, beads, disc or sphere.