US2014295459A1PendingUtilityA1
Markers for identifying tumor cells, methods and kit thereof
Assignee: ONCOSTEM DIAGNOSTICS MAURITIUS PVT LTDPriority: Mar 27, 2011Filed: Jun 13, 2014Published: Oct 2, 2014
Est. expiryMar 27, 2031(~4.7 yrs left)· nominal 20-yr term from priority
Inventors:Manjiri Bakre
A61P 35/00C07K 14/4748G01N 2800/52G01N 33/57515G01N 33/575G01N 33/5759G01N 33/563C12N 5/0695G01N 33/48A61P 15/00G01N 33/57492
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Claims
Abstract
The present disclosure relates to a combination of biological markers for identification of prognosis of cancer. The present disclosure further relates to a method of identifying the said markers, a method of predicting prognosis and a method of planning personalized treatment for cancer. The present disclosure further relates to a kit/test comprising the antibodies against/other methods of detecting said markers for the said prediction.
Claims
exact text as granted — not AI-modifiedWe claim:
1 . A method of prognosis of a subject having breast cancer or suspected of having breast cancer, said method comprising acts of:
a) collecting biological sample from the subject and identifying expression or absence of receptors selected from a group comprising estrogen receptor, progesterone receptor and Human Epidermal Growth Factor Receptor receptor or any combination thereof in cells of the sample to obtain expression of identified cells; b) carrying out immunohistochemistry analysis on the cells of step (a) with antibody against a combination of: biological markers consisting of CD44 and P-cadherin; along with at least one biological marker selected from a group consisting of ABCC4, β-catenin, ABCG2, CD133 and Oct-4 or any combination thereof; c) identifying expression or absence of the receptors and the biological markers in cells of the sample and correlating the identification of the markers with a corresponding outcome based on combination of predictive outcome reference table nos. 11, 12, 13, 14, 15 and 16 for predicting the prognosis of the subject:
TABLE 11
MARKER
ER+/PR+
ER−/PR−
RESULTS
CD44
YES
—
GOOD OUTCOME
LOW EXPRESSION OF CD44 IN
MEMBRANE
YES
—
BAD OUTCOME
HIGH EXPRESSION OF CD44 IN
MEMBRANE
OR
MERE CYTOPLASMIC/NUCLEAR
EXPRESSION
CD44
—
YES
GOOD OUTCOME
HIGH EXPRESSION OF CD44 IN
MEMBRANE
—
YES
BAD OUTCOME
LOW EXPRESSION OF CD44 IN
MEMBRANE
OR
MERE CYTOPLASMIC/NUCLEAR
EXPRESSION
TABLE 12
MARKER
ER+/PR+
ER−/PR−
RESULTS
ABCG2
—
YES
GOOD OUTCOME
HIGH EXPRESSION OF ABCG2
IN NUCLEUS
—
YES
BAD OUTCOME
LOW EXPRESSION OF ABCG2
IN NUCLEUS
TABLE 13
MARKER
ER+/PR+
ER−/PR−
RESULTS
ABCC4
YES
—
GOOD OUTCOME
LOW EXPRESSION OF ABCC4
IN MEMBRANE
YES
—
BAD OUTCOME
HIGH EXPRESSION OF ABCC4
IN MEMBRANE
TABLE 14
MARKER
ER+/PR+
ER−/PR−
RESULTS
CD133
—
YES
GOOD OUTCOME (HER2 −ve)
LOW EXPRESSION OF CD133
IN MEMBRANE
—
YES
BAD OUTCOME (HER2 −ve)
HIGH EXPRESSION OF CD133
IN MEMBRANE
CD133
—
YES
GOOD OUTCOME (HER2 +ve)
HIGH EXPRESSION OF CD133
IN MEMBRANE
—
YES
BAD OUTCOME (HER2 +ve)
LOW EXPRESSION OF CD133
IN MEMBRANE
TABLE 15
MARKER
ER+/PR+
ER−/PR−
RESULTS
P-CADHERIN
YES
—
GOOD OUTCOME
LOW EXPRESSION OF P-
CADHERIN IN MEMBRANE
YES
—
BAD OUTCOME
HIGH EXPRESSION OF P-
CADHERIN IN MEMBRANE
P-CADHERIN
—
YES
GOOD OUTCOME
HIGH EXPRESSION OF P-
CADHERIN IN MEMBRANE
—
YES
BAD OUTCOME
LOW EXPRESSION OF P-
CADHERIN IN MEMBRANE
TABLE 16
MARKER
ER+/PR+
ER−/PR−
RESULTS
β-CATENIN
YES
—
GOOD OUTCOME
LOW EXPRESSION OF β-
CATENIN IN MEMBRANE
YES
—
BAD OUTCOME
HIGH EXPRESSION OF β-
CATENIN IN MEMBRANE
Wherein, the low expression represents percentage intensity of staining of the cells between 0 to 40%, and the high expression represents percentage intensity of staining of the cells between more than 40% and upto 100%.
2 . The method as claimed in claim 1 , wherein the immunohistochemistry analysis is carried out by conventional method and wherein the identification of markers is carried out by visualizing a colored reaction or fluorescence obtained at completion of the method due to staining of the cells from the sample.
3 . The method as claimed in claim 1 , wherein the correlating is based on parameters selected from a group comprising percentage of staining, intensity of staining and location of staining or any combination thereof; and wherein the location of the staining is selected from a group comprising cell membrane, cytoplasm, nucleus, and nuclear membrane or any combination thereof.
4 . The method as claimed in claim 1 , wherein the correlating comprises multiplying the percentage of staining with the intensity of staining to arrive at a predictive score, or wherein the correlating is carried out based on percentage of cells stained in order to predict the prognosis as being good or bad depending on the location of expression of the biological markers.
5 . The combination as claimed in claim 1 , wherein the combination of biological markers consisting of CD44, ABCC4, P-cadherin and β-catenin prognose breast cancer in a subject having cells expressing estrogen receptor or progesterone receptor or both.
6 . The combination as claimed in claim 1 , wherein the combination of biological markers consisting of CD44, ABCG2, CD133 and P-cadherin optionally along with Oct-4 prognose breast cancer in a subject having cells not expressing estrogen receptor and progesterone receptor.
7 . The combination as claimed in claim 1 , wherein the combination of biological markers consisting of CD44, CD133 and P-cadherin prognose breast cancer in a subject having cells expressing Human Epidermal Growth Factor Receptor 2, and not expressing estrogen receptor and progesterone receptor.
8 . A method of treating breast cancer, said method comprising acts of:
a) identifying a combination of biological markers on tumor cells in a biological sample and predicting prognosis of a subject having breast cancer or suspected of having breast cancer; and b) based on the prediction, designing a cancer therapy for suppression of the cancer;
wherein the combination comprises biological markers consisting of CD44 and P-cadherin; along with at least one biological marker selected from a group consisting of ABCC4, β-catenin, ABCG2, CD133 and Oct-4 or any combination thereof.
9 . A kit for prognosis of a subject having breast cancer or suspected of having cancer, said kit comprising antibody against combination of: biological markers consisting of CD44 and P-cadherin; along with at least one biological marker selected from a group consisting of ABCC4, β-catenin, ABCG2, CD133 and Oct-4 or any combination thereof, optionally along with organic solvent, reagent, secondary antibody, enzyme for performing immunohistochemistry and instruction manual.
10 . The kit as claimed in claim 9 , wherein the organic solvent is selected from a group comprising alcohol and xylene or a combination thereof.
11 . The kit as claimed in claim 9 , wherein the combination of biological markers consisting of CD44, ABCC4, P-cadherin and β-catenin prognose breast cancer in the subject having cells expressing estrogen receptor or progesterone receptor or both.
12 . The kit as claimed in claim 9 , wherein the combination of biological markers consisting of CD44. ABCG2, CD133 and P-cadherin optionally along with Oct-4 prognose breast cancer in the subject having cells not expressing estrogen receptor and progesterone receptor.
13 . The kit as claimed in claim 9 , wherein the combination of biological markers consisting of CD44, CD133 and P-cadherin prognose breast cancer in the subject having cells expressing Human Epidermal Growth Factor Receptor 2, and not expressing estrogen receptor and progesterone receptor.Join the waitlist — get patent alerts
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