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1. AU2010275699 - Markers for endometrial cancer

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[ EN ]
CLAIMS
1.               An in vitro diagnostic method for the diagnosis of endometrial cancer comprising detecting the level of the biomarker P4HB in a sample from a patient wherein an increased level of P4HB compared to a control value indicates the existence of endometrial cancer;
wherein said patient is selected from the group comprising: a patient with abnormal uterine bleeding, a pre-menopausal patient, a peri menopausal patient, or post-menopausal patient, a patient having an endometrium with increased thickness; or
wherein said sample is chosen from the group consisting of a tissue sample, blood and/or serum, and uterine fluid.
2.               The in vitro diagnostic method of claim 1, further comprising detecting the level of one or more of GMIP, IKBKE, or EFEMP2.
3.               The in vitro diagnostic method of any one of claim 1 or claim 2, further comprising detecting the level of FASTKD1.
4.               The in vitro diagnostic method of any one of claims 1 to 3, further comprising detecting the level of DDR1.
5.               The in vitro diagnostic method of any one of claims 1 to 4, further comprising detecting the level of SIRT6.
6.               The in vitro diagnostic method of any one of claims 1 to 5 further comprising detecting the level of PHKG2.
7.               The in vitro diagnostic method of any one of claims 1 to 6, further comprising detecting the level of a biomarker chosen from ACAA1, AP1M2, EPS8L2, P2RX4, PPFIBP2, PPP1R16A, CGN, RASSF7, RNF183, TJP3, SOCS2, and DCN.
8.              The in vitro diagnostic method of any one of claims 1 to 7, wherein said patient has a risk factor for endometrial cancer or is being screened for endometrial cancer.
9.              The in vitro diagnostic method of any one of claims 1 to 8, wherein said uterine fluid sample is obtained by aspiration.
10.            The in vitro diagnostic method of any one of claims 1 to 9, wherein the level of the biomarker P4HB, and optionally, one biomarker chosen from GMIP, IKBKE, FASTKD1, DDR1, SIRT6, PHKG2, ACAA1, AP1M2, EPS8L2, P2RX4, PPFIBP2, PPP1R16A, CGN, RASSF7, RNF183, TJP3, EFEMP2, SOCS2, and DCN, is determined with an antibody.
11.            The in vitro diagnostic method of any one of claims 1 to 9, wherein the level of the biomarker P4HB, and optionally, one biomarker chosen from GMIP, FASTKD1, DDR1EFEMP2, SIRT6, PHKG2, ACAA1, AP1M2, EPS8L2, IKBKE, P2RX4, PPFIBP2, PPP1R16A, CGN, RASSF7, RNF183, TJP3, SOCS2, and DCN, is determined by RT-PCR.
12.            The in vitro diagnostic method of any one or claims 2 to 11, wherein from 2 to 20 markers are detected.
13.            The in vitro diagnostic method of any one of claims 1 to 12, wherein one or more additional biomarkers are detected.
14.            The in vitro diagnostic method of claim 13, wherein said one or more additional biomarkers are chosen from differential diagnosis biomarkers, prognostic biomarkers, biomarkers useful for detecting endometrial cancer, biomarkers for classifying endometrial cancer and auxiliary biomarkers for detecting endometrial cancer.
15.            The method of any one of claims 1 to 14, wherein a combination of markers is detected wherein said combination comprises IKBKE and P4HB; IKBKE and SOCS2; P4HB and SOCS2; GMIP and IKBKE; GMIP and P4HB;GMIP, SOCS2, and P4HB; GMIP, IKBKE, and P4HB; IKBKE,P4HB, and SOCS2; GMIP, IKBKE, P4HB, and SOCS2GMIP, SOCS2, P4HB, and EPS8L2;
GMIP, IKBKE, P4HB, and EPS8L2; IKBKE, P4HB, SOCS2, and EPS8L2; GMIP, IKBKE, P4HB, SOCS2, and DDR1; GMIP, IKBKE, P4HB, SOCS2, EPS8L2, and PPP1R16A; GMIP, IKBKE, P4HB, SOCS2, PHKG2, and RASSF7; GMIP, IKBKE, P4HB, SOCS2, EPS8L2, and DDR1; GMIP, IKBKE, P4HB, SOCS2, EPS8L2, PPP1R16A, and DDR1; DDR1, EPS8L2, GMIP, IKBKE, P2RX4, P4HB, PHKG2, PPP1R16A, RASSF7, SIRT6, TJP3, and SOCS2; DDR1, EPS8L2, GMIP, IKBKE, P2RX4, P4HB, PHKG2, PPP1R16A, RASSF7, SIRT6, TJP3, RNF183 and SOCS2;GMIP, IKBKE, P4HB, SOCS2 and FASTKD1; GMIP, IKBKE, P4HB, SOCS2 and DDR1; GMIP, IKBKE, P4HB, SOCS2 and PHKG2; GMIP, IKBKE, P4HB, SOCS2 and SIRT6; GMIP, IKBKE, P4HB, SOCS2 and ACAA1; GMIP, IKBKE, P4HB, SOCS2 and EFEMP2; GMIP, IKBKE, P4HB, SOCS2 and EPS8L2; GMIP, IKBKE, P4HB, SOCS2 and P2RX4; GMIP, IKBKE, P4HB, SOCS2 and PPFIBP2; GMIP, IKBKE, P4HB, SOCS2 and PPP1R16A; GMIP, IKBKE, P4HB, SOCS2, ACAA1 and FASTKD1; GMIP, IKBKE, P4HB, SOCS2, PHKG2 and FASTKD1; GMIP, IKBKE, P4HB, SOCS2, SIRT6 and FASTKD1; ACAA1, AP1M2, EPS8L2, IKBKE, P2RX4, P4HB, PPFIBP2, PPP1R16A, SIRT6, and EFEMP2; GMIP, IKBKE, P4HB, and EFEMP2; DDR1, FASTKD1, PHKG2, SIRT6, SOCS2, GMIP, IKBKE, P4HB, and EFEMP2; DDR1, FASTKD1, PHKG2, SIRT6, GMIP, IKBKE, P4HB, and EFEMP2; P4HB, EFEMP2, IKBKE, GMIP, and FASTKD1; GMIP, IKBKE, P4HB, EFEMP2 and FASTKD1; GMIP, IKBKE, P4HB, EFEMP2and DDR1; GMIP, IKBKE, P4HB, EFEMP2 and PHKG2; GMIP, IKBKE, P4HB, EFEMP2 and SIRT6; GMIP, IKBKE, P4HB, EFEMP2 and ACAA1; GMIP, IKBKE, P4HB, SOCS2 and EFEMP2; GMIP, IKBKE, P4HB, EFEMP2 and EPS8L2; GMIP, IKBKE, P4HB, EFEMP2 and P2RX4; GMIP, IKBKE, P4HB, EFEMP2 and PPFIBP2; GMIP, IKBKE, P4HB, EFEMP2 and PPP1R16A; GMIP, IKBKE, P4HB, EFEMP2, ACAA1 and FASTKD1; GMIP, IKBKE, P4HB, EFEMP2, PHKG2 and FASTKD1; or GMIP, IKBKE, P4HB, EFEMP2, SIRT6 and FASTKD1.
16.            The in vitro diagnostic method of any one of claims 1 to 9 and 11 to 15, comprising providing a uterine fluid sample obtained from a patient with a pipelle device or syringe, wherein the patient has a risk factor or symptom of endometrial cancer;
contacting said sample with an agent capable of preserving, preventing, or lessening the degradation of RNA in said uterine fluid sample; determining in said sample the expression level of mRNA corresponding to said biomarker P4HB and, optionally, one biomarker chosen from ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS and DCN, and one or more endogenous genes using quantitative PCR;
normalizing the expression level of said biomarker P4HB and, optionally, one biomarker chosen from ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS and DCN, with the one or more endogenous genes;
comparing the normalized level of said biomarker P4HB and, optionally, one biomarker chosen from ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS and DCN, to a control value wherein differential expression of said biomarker P4HB and, optionally, one biomarker chosen from ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS and DCN, indicates endometrial cancer or an increased likelihood of endometrial cancer.
17.            The method of claim 16, wherein said one or more endogenous genes are chosen from POLR2A, B2M and PFN1.
18.             Use of a kit comprising a nucleic acid being P4HB mRNA, cDNA, or a complement thereof, to diagnose endometrial cancer in vitro.
19.             Use of a kit comprising a nucleic acid being a primer for P4HB to diagnose endometrial cancer in vitro.
20.             Use of kit comprising a nucleic acid being a probe for P4HB to diagnose endometrial cancer in vitro.
21.            The method of any one of claims 1 to 17, or the use of any one of claims 18 to 20, substantially as hereinbefore described with reference to the figures and/or examples.