Systems and methods for breast cancer detection and risk assessment
View Patent ↗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 detection of a change in a detectable property produced by treating the breast fluid with the aldehyde detecting reagent compared to a control is indicative of a patient having breast cancer or elevated breast cancer risk; and
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 volume of breast aspirate fluid is additionally screened for the presence of at least one additional marker of breast cancer.
6. The method of claim 5 , wherein the solid support comprises at least one additional reagent for detection of the at least one additional marker.
7. The method of claim 1 , wherein the solid support comprises a water-insoluble substrate.
8. The method of claim 1 , wherein a shape of the solid support is generally a tube, test plate, well, beads, disc or sphere.
9. 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;
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;
and wherein a significant reduction in the detectable property compared to a control is indicative that a chemotherapy treatment is generally effective.
10. The method of claim 9 , wherein the aldehyde-detecting reagent is positioned on a solid support.
11. The method of claim 10 , wherein the solid support comprises a pad.
12. The method of claim 9 , wherein the aldehyde detecting reagent comprises Schiff's reagent.
13. The method of claim 9 , wherein the breast fluid is additionally screened for the presence of at least one additional marker of breast cancer.
14. The method of claim 5 , wherein the additional marker of breast cancer is an aldehyde marker comprising low molecular weight aldehydes that are soluble in water.