Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2001-03-08
2003-11-04
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S006120, C435S007100, C435S007200, C435S007900, C436S063000
Reexamination Certificate
active
06642009
ABSTRACT:
BACKGROUND OF THE INVENTION
For several decades significant members of the medical community dedicated to studying breast cancer have believed and shown that the cytological analysis of cells retrieved from nipple discharge from the breast milk ducts can provide valuable information for identifying patients at risk for breast cancer. Papanicolaou himself contributed to the genesis of such a possibility of a “Pap” smear for breast cancer by analyzing the cells contained in nipple discharge. See Papanicolaou et al, “Exfoliative Cytology of the Human Mammary Gland and Its Value in the Diagnosis of Cancer and Other Diseases of the Breast” Cancer (1958) March/April 377-409. See also Petrakis, “Physiological, biochemical, and cytological aspects of nipple aspirate fluid”,
Breast Cancer Research and Treatment
1986; 8:7-19; Petrakis, “Studies on the epidemiology and natural history of benign breast disease and breast cancer using nipple aspirate fluid”
Cancer Epidemiology, Biomarkers and Prevention
(Jan/Feb 1993) 2:3-10; Petrakis, “Nipple Aspirate Fluid in epidemiological studies of breast disease”,
Epidemiologic Reviews
(1993) 15:188-195. More recently, markers have also been detected in nipple fluid. See Sauter et al, “Nipple aspirate fluid: a promising non-invasive method to identify cellular markers of breast cancer risk”,
British Journal of Cancer
76(4): 494-501 (1997). The detection of CEA in fluids obtained by a nipple blot is described in Imayama et al. (1996)
Cancer
78: 1229-1234. Further, an intraductal aspiration method for cytodiagnosis in situations of spontaneous nipple discharge (Hou et al, Acta Cytologica 2000 v. 44:1029-1034) describes use of intraductal aspiration to collect specimens from spontaneously discharging ducts in order to make a cytodiagnosis.
Breast cancer is believed to originate in the lining of a single breast milk duct; and additionally the human breast is believed to contain from 6 to 9 of these ducts. See Sartorius,
JAMA
224 (6): 823-827 (1973). Sartorius describes use of hair-like single lumen catheters that are inserted into breast ducts using an operating microscope and the ducts were flushed with saline solution as described in Cassels, D Mar. 20, 1973, The Medical Post, article entitled “New tests may speed breast cancer detection”. After the fluid was infused, the catheter was removed because it was too small to collect the fluid, the breast was squeezed and fluid that oozed onto the nipple surface was removed from the surface by a capillary tube. Similarly, Love and Barsky, “Breast-duct endoscopy to study stages of cancerous breast disease”,
Lancet
348(9033): 997-999, 1996 describes cannulating breast ducts with a single lumen catheter and infusing a small amount of saline, removing the catheter and squeezing to collect the fluid that returns on the nipple surface. The use of a rigid 1.2 mm ductoscope to identify intraductal papillomas in women with nipple discharge is described in Makita et al (1991)
Breast Cancer Res Treat
18: 179-188. It would be advantageous to collect the ductal fluid from within the duct and so facilitate duct-specific analysis.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a method for preparing a sample for use in diagnosis of breast cancer or pre-cancer.
It is another object of the invention to provide an isolated ductal fluid sample suitable for analyzing breast cancer and pre-cancer.
It is yet another object of the invention to provide a method for analyzing breast markers or epithelial cells.
These and other objects of the invention are provided by one or more of the emobidments described below. In one embodiment a method is provided for preparing a sample for use in the diagnosis of breast cancer or pre-cancer. A ductal fluid sample is isolated from one duct of a breast of a patient. The isolated ductal fluid is not mixed with ductal fluid from any other duct of the breast.
According to another emobidment of the invention an isolated ductal fluid sample is provided. The sample is collected from a breast duct in a breast. The isolated ductal fluid is not mixed with ductal fluid from any other breast duct.
According to still another embodiment of the invention a method is provided for analyzing breast markers or epithelial cells. The presence or absence of a marker in an isolated ductal fluid sample is determined. The sample is collected from a breast duct in a breast. The isolated ductal fluid not mixed with ductal fluid from any other breast duct.
The present invention thus provides the art with improved samples and sampling techniques for diagnosing and prognosing breast cancer and pre-cancer.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
The following preferred embodiments and examples are offered by way of illustration and not by way of limitation.
The invention comprises an isolated ductal fluid sample collected from a breast duct in a breast, the fluid not mixed with ductal fluid from any other breast duct. The isolated ductal fluid sample can be a sample from a non-discharging breast duct. A non-discharging duct is a breast duct that is not spontaneously discharging fluid or material, i.e., a duct which is not leaking fluid to the nipple surface. Spontaneously discharging ducts discharge fluid of various coloration. The spontaneous discharge itself is a warning sign usually requiring further investigation, such as, mammography, ductoscopy, and/or galactography. The present invention provides an isolated ductal fluid sample from a non-discharging duct, i.e., a ductal fluid and/or material sample, a portion of which would not otherwise have contacted the nipple surface. However, the isolated ductal fluid sample may also be from a discharging duct, provided the sample collected is not mixed with ductal fluid from any other duct.
The isolated ductal fluid sample can be examined for the presence of a marker, the absence of a marker, or the state or quality of a particular marker. The markers can comprise those detailed herein and related markers that indicate the status or condition of the breast. The marker status can be used to identify pre-cancer or cancer of the breast. The ductal fluid sample is collected from one duct of a breast of a patient. Ductal fluids may be collected from multiple ducts of a breast or from ducts in both breasts of a patient, e.g., in sequence, provided the fluid and material from each duct is kept separate for analysis from the other ducts. The ducts are also marked or otherwise identified so that follow-up and/or treatment of a duct that indicates the need for treatment can be conducted. The ductal fluid sample when collected or provided is not mixed with ductal fluid from any other duct of the breast.
The number of epithelial cells in a ductal fluid sample may range, for example, from a few to a hundred, to several hundred, to several thousand, and up to tens of thousands, e.g., 20,000 to 100,000 or more cells. At least ten epithelial cells are required to designate an isolated sample as adequate for analysis of the cells. An isolated ductal fluid sample can have 10 or more cells for analysis, and possibly a single clump of cells or more than one clump. A clump comprises a plurality of cells, generally at least about 4 to about 6 cells are in a clump, and the clump can comprise more cells than 6. Samples with one or more clumps can also include individual cells that are distinct from the clump(s). Thus, an isolated sample retrieved by infusing fluid into the duct and collecting the infused fluid mixed with the ductal fluid can provide multiple cells and one or more cell clumps for analysis. The advantage of cell clumps is that the clumping provides a framework for analysis of cell—cell interaction or a cell-to-cell relationship that in turn provides information about the status of the cells themselves. The invention provides the a ductal fluid sample comprising sufficient ductal epithelial cells from a breast duct for an analysis of the breast in which the duct is located. Insufficient ductal epithelial cells in a sample mea
Banner & Witcoff , Ltd.
Cytyc Health Corporation
Huff Sheela
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