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DK2638398T3 - Hidtil ukendt markør til påvisning af blærecancer og/eller inflammatoriske tilstande i blæren. - Google Patents

Hidtil ukendt markør til påvisning af blærecancer og/eller inflammatoriske tilstande i blæren. Download PDF

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Publication number
DK2638398T3
DK2638398T3 DK11846559.0T DK11846559T DK2638398T3 DK 2638398 T3 DK2638398 T3 DK 2638398T3 DK 11846559 T DK11846559 T DK 11846559T DK 2638398 T3 DK2638398 T3 DK 2638398T3
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il8rb
bladder
cancer
btm
bladder cancer
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DK11846559.0T
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Parry John Guilford
Mark Dalphin
Paul O'sullivan
Laimonis Kavalieris
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Pacific Edge Ltd
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    • 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
    • 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
    • C12Q1/6844Nucleic acid amplification reactions
    • C12Q1/6851Quantitative amplification
    • 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
    • G01N33/566Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds
    • 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
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16BBIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B25/00ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression
    • 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/715Assays involving receptors, cell surface antigens or cell surface determinants for cytokines; for lymphokines; for interferons
    • G01N2333/7155Assays involving receptors, cell surface antigens or cell surface determinants for cytokines; for lymphokines; for interferons for interleukins [IL]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
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  • Hospice & Palliative Care (AREA)
  • Oncology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • General Engineering & Computer Science (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Evolutionary Biology (AREA)
  • Medical Informatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Theoretical Computer Science (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Claims (10)

1. Fremgangsmåde til påvisning af blærecancer omfattende: (i) tilvejebringelse af en urinprøve; (ii) påvisning af niveauerne af det humane neutrofilmarkørgen interleukin 8 receptor B (IL8Rb) i tilknytning til blærecancermarkør (BTM)-gener i prøven, hvor BTM-generne omfatter celledelingscyklus 2, GI til S og G2 til M (CDC2), midkine (neuritvækstfrem-mende faktor 2) (MDK), Homeo Box A13 (HOXA13) og insulin-lignende vækstfaktorbindende protein 5 (IGFBP5); og (iii) hvori tilstedeværelse af cancer fastlægges ved sammenligning af niveauerne af IL8Rb og BTM-generne med niveauerne hos normale patienter og/eller patienter med blærecancer og/eller patienter med en inflammatorisk blæretilstand og fastlæggelse af, om patienten har blærecancer, hvori en øgning i niveauerne af BTM-generne uden en øgning i niveauet af IL8Rb indikerer, at patienten har blærecancer, og hvori en øgning i niveauet af IL8Rb indikerer, at patienten haren inflammatorisk blæretilstand.
2. Fremgangsmåde ifølge krav 1, hvori: (a) sandsynligheden for tilstedeværelse af cancer bestemmes ved fastlæggelse af en diagnostisk tærskelværdi baseret på de kendte ekspressionsniveauer af IL8Rb og BTM-generne med niveauerne hos normale patienter og/eller patienter med blærecancer og/eller patienter med en inflammatorisk blæretilstand, eventuelt hvori tærskelværdien fastlægges ved anvendelse af en statistisk metode, og eventuelt hvori den statistiske metode er en hvilken som helst af lineær diskriminantanalyse (LDA), logistisk regression (LogReg), Support Vector Machine (SVM), K-nearest 5 neighbors (KN5N) og Partition Tree Classifier (TREE); og/eller (b) BTM-generne inkluderer mindst et yderligere markørgen udvalgt fra figur 6 eller figur 7.
3. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvori: (a) trinnet med påvisning udføres ved påvisning af niveauerne af mRNA; eller (b) trinnet med påvisning udføres ved påvisning af niveauerne af cDNA, eventuelt ved anvendelse af et oligonukleotid, der er komplementært til mindst en andel af cDNA'et, eller ved anvendelse af qRT-PCR-fremgangsmåde ved anvendelse af en forward-primer og en revers primer.
4. Anvendelse af en anordning til påvisning af en blærecancer i en urinprøve, hvilken anordning omfatter: et substrat med et IL8Rb-gen-capture-reagens og et capture-reagens for blære-tumormarkør (BTM)-gener derpå, hvori BTM-generne omfatter celledelingscyklus 2, GI til S og G2 til M (CDC2), midkine (neuritvækstfremmende faktor 2) (MDK), Homeo Box A13 (HOXA13) og insulin-lignende vækstfaktor-bindende protein 5 (IGFBP5); og en detektor i tilknytning til substratet, hvilken detektor er i stand til at påvise ek spressionen i tilknytning til capture-reagenset, hvori en øgning i niveauerne af BTM-generne uden en øgning i niveauet af IL8Rb indikerer, at patienten har blærecancer, og hvori en øgning i niveauet af IL8Rb indikerer, at patienten haren inflammatorisk blæretilstand.
5. Anvendelse ifølge krav 4, hvori BTM-generne inkluderer mindst en yderligere markør udvalgt fra figur 6 eller figur 7.
6. Anvendelse ifølge et hvilket som helst af kravene 4 til 5, hvori: (a) capture-reagenset er et oligonukleotid; eller (b) capture-reagenset er et antistof, der er specifikt for enten et oligonukleotid, et protein eller et peptid.
7. Anvendelse af et kit til påvisning af blærecancer i en urinprøve, hvilket kit omfatter: et substrat med et IL8Rb-gen-capture-reagens og et capture-reagens for blære-tumormarkør (BTM)-gener derpå, hvori BTM omfatter celledelingscyklus 2, GI til S og G2 til M (CDC2), midkine (neuritvækstfremmende faktor 2) (MDK), Homeo Box A13 (HOXA13) og insulin-lignende vækstfaktor-bindende protein 5 (IGFBP5); et middel til visualisering af et kompleks af capture-midlet og en markør; reagenser og en brugsanvisning, hvori en øgning i niveauerne af BTM-generne uden en øgning i niveauet af IL8Rb indikerer, at patienten har blærecancer, og hvori en øgning i niveauet af IL8Rb indikerer, at patienten haren inflammatorisk blæretilstand.
8. Anvendelse ifølge krav 7, hvori: (a) capture-reagenset er et oligonukleotid; eller (b) capture-reagenset er et antistof, der er selektivt for et oligonukleotid, et protein eller et peptid.
9. Fremgangsmåde til screening for blærecancer omfattende trinnene med: tilvejebringelse af en testurinprøve fra et testsubjekt; måling af tilstedeværelse af IL8Rb-genet og blæretumormarkør (BTM)-generne i testurinprøven, hvori BTM-generne omfatter celledelingscyklus 2, GI til S og G2 til M (CDC2), midkine (neuritvækstfremmende faktor 2) (MDK), Homeo Box A13 (HOXA13) og insulin-lignende vækstfaktor-bindende protein 5 (IGFBP5); og sammenligning af mængden af markører, der er til stede i testurinprøven med en værdi opnået fra en kontrolurinprøve fra et subjekt, der ikke har blærecancer, og/eller med en kontrolprøve med et subjekt, der har en inflammatorisk tilstand i blæren, og fastlæggelse af, om der er blærecancer til stede, hvori en øgning i niveauerne af BTM-generne uden en øgning i niveauet af IL8Rb indikerer tilstedeværelse af blærecancer, og hvori en øgning i niveauet af IL8Rb indikerer tilstedeværelse af en inflammatorisk blæretilstand.
10. Fremgangsmåde ifølge krav 9, hvori: (a) den påviste markør er et oligonukleotid, eventuelt DNA eller RNA; og/eller (c) trinnet med måling anvender et ELISA-assay.
DK11846559.0T 2010-11-12 2011-11-11 Hidtil ukendt markør til påvisning af blærecancer og/eller inflammatoriske tilstande i blæren. DK2638398T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NZ589251A NZ589251A (en) 2010-11-12 2010-11-12 Novel marker for detection of bladder cancer
PCT/NZ2011/000238 WO2012078053A1 (en) 2010-11-12 2011-11-11 Novel marker for detection of bladder cancer and/or inflammatory conditions of the bladder

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CN103314298B (zh) 2016-05-25
WO2012078053A1 (en) 2012-06-14
NO2638398T3 (da) 2018-06-23
SG10201509322YA (en) 2015-12-30
HK1189660A1 (zh) 2014-06-13
AU2017202630A1 (en) 2017-05-18
AU2011339073A1 (en) 2013-06-20
JP5985493B2 (ja) 2016-09-06
EP2638398A1 (en) 2013-09-18
KR20140040070A (ko) 2014-04-02
SG190247A1 (en) 2013-07-31
PT2638398T (pt) 2018-06-01
US11208698B2 (en) 2021-12-28
EP2638398A4 (en) 2014-03-26
BR112013011875A2 (pt) 2021-04-13
ES2667029T3 (es) 2018-05-09
TWI618797B (zh) 2018-03-21
WO2012078053A8 (en) 2013-05-30
CA2817701A1 (en) 2012-06-14
JP2013543974A (ja) 2013-12-09
KR101974135B1 (ko) 2019-04-30
CA2817701C (en) 2021-10-19
US9982305B2 (en) 2018-05-29
EP2638398B1 (en) 2018-01-24
TW201305350A (zh) 2013-02-01
US20170002420A1 (en) 2017-01-05
US20180298452A1 (en) 2018-10-18
NZ589251A (en) 2014-07-25
BR112013011875B1 (pt) 2022-06-14
CN103314298A (zh) 2013-09-18

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