Methods of determining therapies based on single cell characterization of circulating tumor cells (ctcs) in metastatic disease
AssigneeEpic Sciences, Inc.
InventorRyan Dittamore
Life of this patent
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Abstract
The disclosure provides a method of identifying a cell type, or the presence or absence of a cell type, associated with response to abiraterone or enzalutamide in a cancer patient, comprising (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to identify and enumerate circulating tumor cells (CTC); (b) isolating the CTCs from the sample; (c) individually characterizing parameters to generate a profile for each of the CTCs, and (d) identifying a biomarker CTC, wherein presence or absence of the biomarker CTC indicates a responsiveness in the patient to abiraterone or enzalutamide.
Claims20
A method of identifying or determining the presence or absence of a cell type associated with response to abiraterone or enzalutamide in a cancer patient, comprising:
- (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to identify and enumerate circulating tumor cells (CTC);
- (b) individually characterizing digital pathology parameters to generate a profile for each of the CTCs, wherein the parameters comprise:
- (i) size of the nucleus;
- (ii) nuclear entropy;
- (iii) number of nucleoli or size of the cytoplasm;
- and
- (iv) optionally other features listed in Table 1;
- (c) classifying individual cells into CTC subtypes;
- and
- (d) identifying or determining the presence or absence of a biomarker CTC in the CTC subtypes,
- wherein identification of the biomarker CTC indicates a cell type associated with response in the patient to abiraterone;
- or
- wherein absence of the biomarker CTC indicates the absence of a cell type associated with response in the patient to enzalutamide.
(canceled)
6-12. (canceled)
A method of identifying a cancer patient for treatment with a drug, comprising:
- (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to identify and enumerate circulating tumor cells (CTC);
- (b) individually characterizing digital pathology parameters to generate a profile for each of the CTCs, wherein the parameters comprise:
- (i) size of the nucleus;
- (ii) nuclear entropy;
- (iii) number of nucleoli or size of the cytoplasm;
- and
- (iv) optionally other features listed in Table 1;
- (c) classifying individual cells into CTC subtypes;
- and
- (d) determining the presence or absence of a biomarker CTC in the CTC subtypes,
- wherein presence of the biomarker CTC indicates to administer abiraterone to the cancer patient, or
- wherein absence of the biomarker CTC indicates to administer enzalutamide to the cancer patient.
(canceled)
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A method of predicting responsiveness in a cancer patient to treatment with abiraterone or enzalutamide, comprising:
- (a) performing a direct analysis comprising immunofluorescent staining and morphological characterization of nucleated cells in a blood sample obtained from the patient to identify and enumerate circulating tumor cells (CTC);
- (b) individually characterizing digital pathology parameters to generate a profile for each of the CTCs, wherein the parameters comprise:
- (i) size of the nucleus;
- (ii) nuclear entropy;
- (iii) number of nucleoli or size of the cytoplasm;
- and
- (iv) optionally other features listed in Table 1;
- (c) classifying individual cells into CTC subtypes;
- and
- (d) identifying or determining the presence or absence of a biomarker CTC in the CTC subtypes,
- wherein identification of the biomarker CTC predicts responsiveness of the cancer patient to treatment with abiraterone, or
- wherein absence of the biomarker CTC predicts responsiveness of the cancer patient to treatment with enzalutamide.
(canceled)
26-64. (canceled)
Dependencies are inferred from the claim text.