# US 2014/0193927 A1 · Prediction of recurrence for bladder cancer by a protein signature in tissue samples

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- Number: US 2014/0193927 A1
- Document ID: US20140193927A1
- Status: Published application
- Kind: A1
- Application number: 14/124,580
- Filed: 2012-06-08
- Published: 2014-07-10
- Earliest claimed: 2011-06-10
- Assignees: Institut Curie; Deutsches Krebsforschungszentrum
- Inventors: Christoph Schröder; Harish Srinivasan; Jörg Hiheisel; François Radvanyi
- Web page: https://patentgrep.com/patent/US20140193927A1

## CPC

- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N 2800/54: Determining the risk of relapse
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- 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

The present invention pertains to the field of cancer prediction. Specifically, it relates to a method for predicting the risk of recurrence of bladder cancer in a subject after treatment of bladder cancer comprising the steps of determining the amount of at least one biomarker selected from the biomarkers shown in Table, and comparing the amount of said at least one biomarker with a reference amount for said at least one biomarker, whereby the risk of recurrence of bladder cancer is to be predicted. The present invention also contemplates a method for identifying a subject being in need of a further bladder cancer therapy. Encompassed are, furthermore, diagnostic devices and kits for carrying out said methods.

## Claims

### Claim at position 1

1-15. (canceled)

### Claim 16

A method for predicting the risk of recurrence of bladder cancer in a subject, comprising the steps of:
(a) determining the amount of at least one biomarker selected from the biomarkers shown in Table 1 in a sample from the subject; and
(a) comparing the amount of the at least one biomarker with a reference amount for the at least one biomarker, whereby the risk of recurrence of bladder cancer is to be predicted.

### Claim 17 (depends on 16)

The method of claim 16, wherein the at least one biomarker is selected from the group of biomarkers listed in Table 2, and wherein an increase in the at least one biomarker as compared to the reference amount indicates that the subject is at risk of recurrence of bladder cancer.

### Claim 18 (depends on 16)

The method of claim 16, wherein the at least one biomarker is selected from the group of biomarkers listed in Table 3, and wherein a decrease in the at least one biomarker as compared to the reference amount indicates that the subject is at risk of recurrence of bladder cancer.

### Claim 19 (depends on 16)

The method of claim 16, wherein the risk of recurrence of bladder cancer is predicted after surgery comprising removal of a tumor.

### Claim 20 (depends on 19)

The method of claim 19, wherein the surgery is transurethral resection, or radical cystectomy, or partial cystectomy.

### Claim 21 (depends on 16)

The method of claim 16, wherein said sample is tumor tissue, or a blood, serum or plasma sample.

### Claim 22 (depends on 16)

The method of claim 16, wherein the reference amount is derived from a subject or group of subjects known to be at risk for recurrence of bladder cancer, or from a subject or group of subjects known to not be at risk for recurrence of bladder cancer.

### Claim 23

A method for identifying a subject in need of a further bladder cancer therapy after treatment of bladder cancer, comprising the steps of:
(a) determining the amount of at least one biomarker selected from the biomarkers shown in Table 1 in a sample of a subject; and
(b) comparing the amount of the at least one biomarker with a reference amount for the at least one biomarker, whereby a subject in need of further bladder cancer therapy is to be identified.

### Claim 24 (depends on 23)

The method of claim 23, wherein the treatment of bladder cancer is surgery comprising removal of a tumor, and/or wherein the further bladder cancer therapy is adjuvant intravesical therapy.

### Claim 25

A method for predicting the risk of progression of bladder cancer in a subject suffering from bladder cancer, comprising the steps of:
(a) determining the amount of at least one biomarker selected from the biomarkers shown in Table 1 in a sample from the subject; and
(b) comparing the amount of the at least one biomarker with a reference amount for the at least one biomarker, whereby the risk of progression of bladder cancer is to be predicted.

### Claim 26

A device for predicting recurrence of bladder cancer in a sample of a subject comprising:
(a) an analyzing unit for the sample of the subject comprising a detection agent for at least one biomarker as shown in Table 1, wherein the detection agent allows for the determination of the amount of the at least one biomarker in the sample; and
(b) an evaluation unit, which is operatively linked to the analyzing unit, wherein the evaluation unit comprises a data processing unit and a data base, wherein the data base comprises a stored reference and the data processing unit is capable of carrying out a comparison of the amount of the at least one biomarker determined by the analyzing unit and the stored reference, thereby establishing the prediction.

### Claim 27 (depends on 26)

The device of claim 26, wherein the detection agent is an antibody which specifically binds the biomarker.

### Claim 28

A kit comprising (i) a detection agent for determining an amount of at least one biomarker as shown in Table 1, and (ii) evaluation instructions for establishing a diagnosis.

### Claim 29 (depends on 28)

The kit of claim 28, wherein the detection agent is an antibody which specifically binds the biomarker.

### Claim 30

A composition comprising a detection agent which specifically binds to the biomarker LMNA (human Lamin A), a detection agent which specifically binds to the biomarker YBOX1 (Nuclease-sensitive element-binding protein 1), and a detection agent which specifically binds to the biomarker JUN (Transcription factor AP-1).
