# US 2014/0193814 A1 · Abca1 downregulation in prostate cancer

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- Number: US 2014/0193814 A1
- Document ID: US20140193814A1
- Status: Published application
- Kind: A1
- Application number: 14/148,241
- Filed: 2014-01-06
- Published: 2014-07-10
- Earliest claimed: 2013-01-07
- Assignees: The Cleveland Clinic Foundation
- Applicants: The Cleveland Clinic Foundation
- Inventors: Angela H. Ting; Byron H. Lee
- Web page: https://patentgrep.com/patent/US20140193814A1

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/57555: of the prostate
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/154: Methylation markers
- C12Q 2600/158: Expression markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A method of providing a prognosis or diagnosis of prostate cancer in a subject is described. The method includes obtaining a urine or prostate sample from the subject; determining the level of expression of ABCA1 in the sample; and comparing the level of expression of ABCA1 in the sample to the level of a control sample, wherein a decreased level of ABCA1 expression compared to the control indicates the subject has prostate cancer or a more severe form of prostate cancer. Methods of treating subjects identified as having prostate cancer, and kits for carrying out the method of prognosis or diagnosis are also described.

## Claims

### Claim 1

A method of providing a prostate cancer prognosis in a subject having prostate cancer, comprising:
(a) obtaining a urine or prostate sample from the subject;
(b) determining the level of expression of ABCA1 in the sample; and
(c) comparing the level of expression of ABCA1 in the sample to the level of a control sample, wherein a decreased level of ABCA1 expression compared to the control indicates the subject has a more severe form of prostate cancer.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sample is a prostate sample.

### Claim 3 (depends on 1)

The method of claim 1, wherein the level of expression of ABCA1 is determined by measuring the level of ABCA1 mRNA.

### Claim 4 (depends on 1)

The method of claim 1, wherein the level of expression of ABCA1 is determined by measuring the level of ABCA1 protein.

### Claim 5 (depends on 4)

The method of claim 4, wherein the level of ABCA1 protein is determined by an immunoassay.

### Claim 6 (depends on 5)

The method of claim 5, wherein the immunoassay includes the step of contacting the sample with a polyclonal antibody that is specific for the ABCA1 protein.

### Claim 7 (depends on 5)

The method of claim 5, wherein the immunoassay includes the step of contacting the sample with a monoclonal antibody that is specific for the ABCA1 protein.

### Claim 8 (depends on 5)

The method of claim 5, wherein the immunoassay includes the step of contacting the sample with an antibody that was generated using the ABCA1 antigen sequence CRLFSDARRLLLYSQKDTSMKDM (SEQ ID NO: 1).

### Claim 9 (depends on 1)

The method of claim 1, wherein the level of expression of ABCA1 is measured by detecting the methylation of an ABCA1 promoter region, wherein hypermethylation of the ABCA1 promoter region indicates a decreased level of ABCA1 expression.

### Claim 10

A method of diagnosing prostate cancer in a subject, comprising:
(a) obtaining a urine or prostate sample from the subject;
(b) determining the level of expression of ABCA1 in the sample; and
(c) comparing the level of expression of ABCA1 in the sample to the level of a control sample, wherein a decreased level of ABCA1 expression compared to the control indicates the subject has prostate cancer.

### Claim 11 (depends on 10)

The method of claim 10, wherein the sample is a prostate sample.

### Claim 12 (depends on 10)

The method of claim 10, wherein the level of expression of ABCA1 is determined by measuring the level of ABCA1 mRNA.

### Claim 13 (depends on 10)

The method of claim 10, wherein the level of expression of ABCA1 is determined by measuring the level of ABCA1 protein.

### Claim 14 (depends on 13)

The method of claim 13, wherein the level of ABCA1 protein is determined by an immunoassay.

### Claim 15 (depends on 10)

The method of claim 10, wherein the level of expression of ABCA1 is measured by detecting the methylation of an ABCA1 promoter region, wherein hypermethylation of the ABCA1 promoter region indicates a decreased level of ABCA1 expression.

### Claim 16 (depends on 10)

The method of claim 10, further comprising the step of administering or prescribing a prostate cancer antitumor therapy to a subject having a decreased level of ABCA1 expression.

### Claim 17

A kit for conducting diagnosis or prognosis of prostate cancer in a subject, comprising:
antibody specific for the ABCA1 protein,
a reference value or control sample for ABCA1 levels,
reagents necessary for conducting an immunoassay, and
a package for holding the antibody, the reference value or control sample, and the reagents.

### Claim 18 (depends on 17)

The kit of claim 17, wherein the kit further comprises instructions for using the kit to carry out a method of diagnosing or providing a prognosis of prostate cancer for a subject using the antibody, reagents, and the reference values or control samples.

### Claim 19 (depends on 17)

The kit of claim 17, wherein the antibody is a monoclonal antibody.

### Claim 20 (depends on 17)

The kit of claim 17, wherein the antibody was generated using the ABCA1 antigen sequence CRLFSDARRLLLYSQKDTSMKDM (SEQ ID NO: 1).
