Methods for detection of breast cancer
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.