Methods for detection of breast cancer

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 for detecting neoplasia, a precancerous condition, or cancer of the breast in a subject comprising treating a sample of breast fluid from the subject with an aldehyde detecting reagent where the detection of a change produced by the aldehyde detecting reagent compared to a control is indicative of neoplasia, a precancerous condition, or cancer.  
   
   
       2 . A method of  claim 1  comprising the following steps: 
 a) obtaining a sample of breast fluid from a subject;    b) depositing the sample on a solid support;    c) treating the sample with an aldehyde detecting reagent without any prewashing;    d) detecting a calorimetric change produced in the sample, where detection of a colorimetric change compared to a control is indicative of neoplasia, a precancerous condition, or cancer of the breast.    
   
   
       3 . A method of  claim 1  for detecting a neoplasia, a precancerous condition, or cancer of the breast in a subject, which method comprises: 
 a) obtaining a sample of breast fluid from a subject;    b) depositing the sample on a solid support;    c) treating the sample on the support with a Schiff's reagent without any prewashing; and    d) detecting a colorimetric change resulting from the reaction of the sample and Schiff's reagent wherein a calorimetric change is indicative of neoplasia, a precancerous condition, or cancer of the breast.    
   
   
       4 . (canceled)  
   
   
       5 . A method of  claim 1  for detecting the presence of neoplasia, a precancerous condition, or cancer of the breast, which method comprises: 
 (a) obtaining a sample of breast fluid from the nipple of one or both non-lactating breasts of a subject;    (b) depositing the collected sample on a solid water-insoluble support;    (c) treating the sample on the support with a Schiff's reagent without any prewashing;    (d) washing the sample; and    (e) screening for neoplasia, a precancerous condition, or cancer of the breast by persistent purple coloration produced in the sample.    
   
   
       6 . A method of  claim 5  wherein the breast fluid is breast discharge, ductal secretion, or nipple aspirate fluid.  
   
   
       7 . A method of  claim 2  wherein the sample containing contains an aldehyde marker associated with breast cancer, and comprising in step d) detecting the presence of the aldehyde marker in the sample.  
   
   
       8 . A method of  claim 7  wherein the aldehyde marker is capable of reacting with a Schiff's reagent to produce a colorimetric change.  
   
   
       9 . A method as claimed in  claim 7  wherein the aldehyde marker comprises low molecular weight aldehydes that are soluble in water.  
   
   
       10 . (Canceled)  
   
   
       11 . (Canceled)  
   
   
       12 . A method of  claim 1  for detecting the presence of neoplasia, a precancerous condition, or cancer of the breast, which method consists essentially of obtaining a sample of breast fluid from the breast of a subject; treating the sample with a Schiff's reagent; and, detecting neoplasia, a precancerous condition, or cancer of the breast based upon the coloration produced in the sample by the treatment.  
   
   
       13 . A method as claimed in  claim 12  wherein the coloration is distinguished from other colorations.  
   
   
       14 . A method as claimed in  claim 12  wherein the breast fluid is nipple discharge, ductal secretion, nipple aspirate or nipple aspirate fluid.  
   
   
       15 . (Canceled)  
   
   
       16 . (Canceled)  
   
   
       17 . A method as claimed in  claim 12  wherein the sample is adsorbed on a water-insoluble substrate.  
   
   
       18 . A method as claimed in  claim 17  wherein the water-insoluble substrate is made from polyester fibre or glass fibre fabrics.  
   
   
       19 . A method as claimed in  claim 2  wherein the sample is additionally screened for the presence of other markers that are indicators of breast cancer.  
   
   
       20 . (Canceled)  
   
   
       21 . (Canceled)  
   
   
       22 . (Canceled)  
   
   
       23 . A kit for carrying out a method of  claim 12 .  
   
   
       24 . A method of  claim 1  for detecting the presence of neoplasia, a precancerous condition, or cancer of the breast, which method consists essentially of obtaining a sample of breast fluid from a subject; directly treating the sample with a Schiff's reagent and, detecting neoplasia, a precancerous condition, or cancer of the breast based upon the coloration produced in the sample by the treatment.  
   
   
       25 . A method of  claim 1  for detecting the presence of neoplasia, a precancerous condition, or cancer of the breast, which method consists essentially of obtaining a sample of breast fluid from a subject; treating the sample with a Schiff's reagent without a step of adding an enzyme and, detecting neoplasia, a precancerous condition, or cancer of the breast.  
   
   
       26 . A method of  claim 25  wherein the enzyme is galactose oxidase and optionally catalase.  
   
   
       27 . A method as claimed in  claim 1  comprising: 
 a) obtaining a sample of breast fluid from a subject;    b) depositing the sample on a solid support;    c) treating the sample with a step consisting essentially of adding a Schiff's reagent; and    e) detecting a calorimetric change resulting from the reaction of aldehyde markers on the sample and Schiff's reagent wherein a calorimetric change is indicative of neoplasia, precancer or cancer of the breast.    
   
   
       28 . A method of  claim 7  wherein the aldehyde marker comprises aldehydes derived from plasmalogens.