Materials and methods for diagnosis, prognosis and assessment of therapeutic/prophylactic treatment of prostate cancer
AssigneeAbbott Molecular Inc.
InventorsYing Zhang, Larry Morrison, Ekaterina Pestova, Irina Sokolova
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Abstract
A method to detect prostate cancer comprising contacting a sample of prostate cells from the patient with a set of detectably labeled probes under hybridization conditions and determining the presence of chromosomal abnormalities in prostate tumor tissue, PIN (intra-epithelial neoplasia), histologically benign tissue and benign prostatic hyperplasia (BPH); a method to combine immunofluorescence and FISH (IF-FISH) to facilitate the assessment of chromosomal abnormalities; a set of probes; and a kit comprising the set of probes and instructions for diagnosing prostate cancer in a patient.
Claims36
A method of detecting prostate cancer in a patient, which method comprises:
- contacting a sample of prostate cells from the patient with a set of detectably labeled probes comprising a locus-specific probe for MYC, a locus-specific probe for phosphatase and tensin homolog (PTEN), a centromeric probe for chromosome 8, and a centromeric probe for chromosome 7 under hybridization conditions and determining the presence of chromosomal abnormalities,
- wherein a MYC % gain (% gain is % of cells with MYC>2 signals) of greater than 35 (with a range of 2 to 50), a PTEN % loss (% loss is % of cells with <2 signals) of greater than 33 (with a range of 29 to 33), a chromosome 8% gain (% gain is % of cells with >2 signals) of greater than 34 (with a range of 32 to 34), and a chromosome 7% abnormal (% abnormal is % of cells with >2 or <2 signals) greater than 28 (with a range of 24 to 29) in a sample of prostate cells from a tumor region of interest (ROI) or a benign ROI of the prostate of the patient indicates that the patient has prostate cancer,
- whereupon prostate cancer in the patient is detected.
A set of probes comprising a locus-specific probe for MYC, a locus-specific probe for phosphatase and tensin homolog (PTEN), a centromeric probe for chromosome 8, and a centromeric probe for chromosome 7, wherein the set of probes optionally further comprises an anti-α-methylacyl-CoA racemase (AMACR) antibody, which can be detectably labeled.
A kit comprising:
- (a) a set of probes that enables diagnosis of prostate cancer in a patient, wherein the set of probes comprises a locus-specific probe for MYC, a locus-specific probe for phosphatase and tensin homolog (PTEN), a centromeric probe for chromosome 8, and a centromeric probe for chromosome 7, and
- (b) instructions for diagnosing prostate cancer in a patient, wherein the instructions comprise determining in a sample of prostate cells obtained from the patient the presence of chromosomal abnormalities,
- wherein a MYC % gain (% gain is % of cells with MYC>2 signals) of greater than 35 (with a range of 2 to 50), a PTEN % loss (% loss is % of cells with <2 signals) of greater than 33 (with a range of 29 to 33), a chromosome 8% gain (% gain is % of cells with >2 signals) of greater than 34 (with a range of 32 to 34), and a chromosome 7% abnormal (% abnormal is % of cells with >2 or <2 signals) greater than 28 (with a range of 24 to 29) in a sample of prostate cells from a tumor region of interest (ROI) or a benign ROI of the prostate of the patient indicates that the patient has prostate cancer.
A method of detecting prostate cancer in a patient, which method comprises:
- contacting a sample of prostate cells from the patient with a set of detectably labeled probes comprising a locus-specific probe for MYC, a locus-specific probe for lipoprotein lipase (LPL), a locus-specific probe for phosphatase and tensin homolog (PTEN), and a centromeric probe for chromosome 8 under hybridization conditions and determining the presence of chromosomal abnormalities,
- wherein a MYC/LPL % gain (% gain is % of cells with MYC/LPL>1) of greater than 14 (with a range of 12 to 22), a chromosome 8% abnormal (% abnormal is % of cells with >2 or <2 signals) of greater than 34 (with a range of 26 to 40), a PTEN % loss (% loss is % of cells with <2 signals) of greater than 44 (with a range of 22 to 54), or a MYC/chromosome 8% gain (% gain is % of cells with MYC/chromosome 8>1) greater than 16 (with a range of 10 to 18) in a sample of prostate cells from a tumor region of interest (ROI) of the prostate of the patient indicates that the patient has prostate cancer, and
- wherein a MYC/LPL % gain of greater than 18 (with a range of 12 to 19), a chromosome 8% abnormal of greater than 32 (with a range of 25 to 34), a PTEN % loss of greater than 26 (with a range of 22 to 28), or a MYC/chromosome 8% gain greater than 16 (with a range of 9 to 18) in a sample of prostate cells from a benign ROI of the prostate of the patient indicates that the patient has prostate cancer,
- whereupon prostate cancer in the patient is detected.
A set of probes comprising a locus-specific probe for MYC, a locus-specific probe for lipoprotein lipase (LPL), a locus-specific probe for phosphatase and tensin homolog (PTEN), and a centromeric probe for chromosome 8, wherein the set of probes optionally further comprises an anti-α-methylacyl-CoA racemase (AMACR) antibody, which can be detectably labeled.
A kit comprising:
- (a) a set of probes that enables diagnosis of prostate cancer in a patient, wherein the set of probes comprises a locus-specific probe for MYC, a locus-specific probe for lipoprotein lipase (LPL), a locus-specific probe for phosphatase and tensin homolog (PTEN), and a centromeric probe for chromosome 8 and
- (b) instructions for diagnosing prostate cancer in a patient, wherein the instructions comprise determining in a sample of prostate cells obtained from the patient the presence of chromosomal abnormalities,
- wherein a MYC/LPL % gain (% gain is % of cells with MYC/LPL>1) of greater than 14 (with a range of 12 to 22), a chromosome 8% abnormal (% abnormal is % of cells with >2 or <2 signals) of greater than 34 (with a range of 26 to 40), a PTEN % loss (% loss is % of cells with <2 signals) of greater than 44 (with a range of 22 to 54), or a MYC/chromosome 8% gain (% gain is % of cells with MYC/chromosome 8>1) greater than 16 (with a range of 10 to 18) in a sample of prostate cells from a tumor region of interest (ROI) of the prostate of the patient indicates that the patient has prostate cancer, and
- wherein a MYC/LPL % gain of greater than 18 (with a range of 12 to 19), a chromosome 8% abnormal of greater than 32 (with a range of 25 to 34), a PTEN % loss of greater than 26 (with a range of 22 to 28), or a MYC/chromosome 8% gain greater than 16 (with a range of 9 to 18) in a sample of prostate cells from a benign ROI of the prostate of the patient indicates that the patient has prostate cancer.
Dependencies are inferred from the claim text.