DK2456889T3 - Markører for endometriel cancer - Google Patents

Markører for endometriel cancer Download PDF

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Publication number
DK2456889T3
DK2456889T3 DK10736990.2T DK10736990T DK2456889T3 DK 2456889 T3 DK2456889 T3 DK 2456889T3 DK 10736990 T DK10736990 T DK 10736990T DK 2456889 T3 DK2456889 T3 DK 2456889T3
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Denmark
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cáncer
endometrial
biomarkers
p4hb
level
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DK10736990.2T
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English (en)
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Posada Miguel Abal
Andreas Doll
Moreno Antonio Gil
Tamara Maes
Cristina Perez
Puigjaner Jaume Reventós
Elisabet Rossell
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Geadic Biotec Aie
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069Reproductive system, e.g. ovaria, uterus, testes, prostate
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6813Hybridisation assays
    • C12Q1/6834Enzymatic or biochemical coupling of nucleic acids to a solid phase
    • C12Q1/6837Enzymatic or biochemical coupling of nucleic acids to a solid phase using probe arrays or probe chips
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57407Specifically defined cancers
    • G01N33/57442Specifically defined cancers of the uterus and endometrial
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/112Disease subtyping, staging or classification
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/156Polymorphic or mutational markers
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/158Expression markers
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/16Primer sets for multiplex assays
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/60Complex ways of combining multiple protein biomarkers for diagnosis

Claims (29)

1. ln vitro diagnostisk fremgangsmáde til diagnose af endometriel cáncer, hvilken frem-gangsmáde omfatter detektion af niveauet af biomarkoren P4HB i en preve fra en pati-ent, hvor et foreget niveau af P4HB i sammenligning med en kontrolvaerdi indikerer forekomst af endometriel cáncer.
2. In vitro diagnostisk fremgangsmáde ifelge krav 1, som desuden omfatter detektion af niveauet af GMIP, IKBKE eller EFEMP2.
3. In vitro diagnostisk fremgangsmáde ifelge krav 1, som desuden omfatter detektion af niveauet af FASTKD1.
4. In vitro diagnostisk fremgangsmáde ifolge krav 1, som desuden omfatter detektion af niveauet af DDR1.
5. In vitro diagnostisk fremgangsmáde ifolge krav 1, som desuden omfatter detektion af niveauet af SIRT6.
6. In vitro diagnostisk fremgangsmáde ifolge krav 1, som desuden omfatter detektion af niveauet af PHKG2.
7. In vitro diagnostisk fremgangsmáde ifolge krav 1, som desuden omfatter detektion af niveauet af en biomarkor, der er valgt blandt ACAA1, AP1M2, EPS8L2, P2RX4, PPFIBP2, PPP1R16A, CGN, RASSF7, RNF183, TJP3, SOCS2 og DCN.
8. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 7, hvor patienten har en risikofaktor for endometriel cáncer eller er under screening for endometriel cáncer.
9. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 8, hvor proven fra patienten erfra en patient med abnorm uterin blodning.
10. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 9, hvor proven fra patienten erfra en patient, som har et endometrium med foroget tyk-kelse.
11. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 10, hvor proven fra patienten erfra en prae-menopausal, peri-menopausal eller post-meno-pausal patient.
12. In vitro diagnostisk fremgangsmáde ifolge krav 11, hvor patienten er post-meno-pausal.
13. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 12, hvor proven er valgt blandt en vaevsprove, blod og/eller serum og uterin vaeske.
14. In vitro diagnostisk fremgangsmáde ifolge krav 13, hvor proven er en uterin vae-skeprove.
15. In vitro diagnostisk fremgangsmáde ifolge krav 14, hvor den uterine vaeskeprove er opnáet ved aspiration.
16. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 15, hvor niveauet af biomarkoren P4HB og eventuelt én biomarkor, der er valgt blandt GMIP, IKBKE, FASTKD1, DDR1, SIRT6, PHKG2, ACAA1, AP1M2, EPS8L2, P2RX4, PPFIBP2, PPP1R16A, CGN, RASSF7, RNF183, TJP3, EFEMP2, SOCS2 og DCN, bestemmes med et antistof.
17. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 15, hvor niveauet af biomarkoren P4HB og eventuelt én biomarkor, der er valgt blandt GMIP, IKBKE, FASTKD1, DDR1,SIRT6, PHKG2, ACAA1, AP1M2, EPS8L2, P2RX4, PPFIBP2, PPP1R16A, CGN, RASSF7, RNF183, TJP3, EFEMP2, SOCS2 og DCN, bestemmes ved RT-PCR.
18. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 2 til 17, hvor der detekteres fra 2 til 20 markorer.
19. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 18, hvor der detekteres én eller flere yderligere biomarkorer.
20. In vitro diagnostisk fremgangsmáde ifolge krav 19, hvor den ene eller de flere yderligere biomarkorer er valgt blandt differential diagnose-biomarkorer, prognostiske biomarkorer, biomarkorer, som er nyttige til detektion af endometriel cáncer, biomarkorer til klassificering af endometriel cáncer og hjaelpebiomarkorer til detektion af endometriel cáncer.
21. In vitro diagnostisk fremgangsmáde ifolge et hvilket som helst af kravene 1 til 15 og 17 til 20, hvilken fremgangsmáde omfatter, at der tilvejebringes en uterin vaeskeprove, som er opnáet fra en patient med en pipelleindretning eller sprojte, hvor patienten har en risikofaktor for eller et symptom pá endometriel cáncer; proven bringes i kontakt med et middel, som er i stand til at konservere, forebygge eller formindske nedbrydningen af RNA i den uterine vaeskeprove; i proven bestemmes ekspressionsniveauet af mRNA svarende til biomarkoren P4HB og eventuelt én biomarkor, der er valgt blandt ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS2 og DCN, og ét eller flere endogene gener under an-vendelse af kvantitativ PCR; ekspressionsniveauet af biomarkoren P4HB og eventuelt én biomarkor, der er valgt blandt ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS2 og DCN, normaliseres med det ene eller de flere endogene gener; det normaliserede niveau af biomarkoren P4HB og eventuelt én biomarkor, der er valgt blandt ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS2 og DCN, sammenlignes med en kontrolvaerdi, hvor forskellig ekspression af biomarkoren P4HB og eventuelt én biomarkor, der er valgt blandt ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS2 og DCN, indikerer endometriel cáncer eller en foroget sandsynlighed for endometriel cáncer.
22. Fremgangsmáde ifolge krav 21, hvor det ene eller de flere endogene gener er valgt blandt POLR2A, B2M og PFN1.
23. Anvendelse af en nukleinsyre, som er P4HB mRNA, cDNA eller et komplement deraf, til diagnosticering af endometriel cáncer in vitro.
24. Anvendelse af en nukleinsyre, som er en primer for P4HB, til diagnosticering af endometriel cáncer in vitro.
25. Anvendelse af en nukleinsyre, som er en probe for P4HB, til diagnosticering af endometriel cáncer in vitro.
26. Anvendelse af et antistof mod P4HB til diagnosticering af endometriel cáncer in vitro.
27. Anvendelse af et kit, som omfatter en primer for P4HB som defineret i krav 24, til diagnosticering af endometriel cáncer in vitro.
28. Anvendelse af et kit, som omfatter en probe som defineret i krav 25, til diagnosticering af endometriel cáncer in vitro.
29. Anvendelse af et kit, som omfatter et antistof som defineret i krav 26, til diagnosticering af endometriel cáncer in vitro.
DK10736990.2T 2009-07-24 2010-07-23 Markører for endometriel cancer DK2456889T3 (da)

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EP09166398 2009-07-24
PCT/EP2010/004550 WO2011009637A2 (en) 2009-07-24 2010-07-23 Markers for endometrial cancer

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EP (2) EP2848700B1 (da)
JP (1) JP5934093B2 (da)
KR (1) KR101828290B1 (da)
CN (2) CN102549169B (da)
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BR (1) BR112012001469B1 (da)
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HR (1) HRP20141062T1 (da)
IN (1) IN2012DN00707A (da)
MX (1) MX2012000921A (da)
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RU2012106432A (ru) 2013-08-27
EP2456889A2 (en) 2012-05-30
IN2012DN00707A (da) 2015-06-19
CA2767914C (en) 2020-02-25
CN102549169B (zh) 2016-02-24
RU2596394C2 (ru) 2016-09-10
PT2456889E (pt) 2014-11-21
ES2654340T3 (es) 2018-02-13
CN102549169A (zh) 2012-07-04
BR112012001469B1 (pt) 2021-08-10
US20120122726A1 (en) 2012-05-17
KR101828290B1 (ko) 2018-02-12
PL2456889T3 (pl) 2015-02-27
EP2848700B1 (en) 2017-10-04
MX2012000921A (es) 2012-06-12
WO2011009637A2 (en) 2011-01-27
HRP20141062T1 (hr) 2015-01-02
ES2523683T3 (es) 2014-11-28
US9046522B2 (en) 2015-06-02
WO2011009637A3 (en) 2011-04-14
JP2013500001A (ja) 2013-01-07
EP2456889B1 (en) 2014-09-03
BR112012001469A2 (pt) 2020-08-11
JP5934093B2 (ja) 2016-06-15
US20150337392A1 (en) 2015-11-26
CN105132529A (zh) 2015-12-09
AU2010275699A1 (en) 2012-02-02
CA2767914A1 (en) 2011-01-27
KR20120047334A (ko) 2012-05-11
AU2010275699B2 (en) 2016-06-16
EP2848700A1 (en) 2015-03-18

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