DK2438193T3 - Fremgangsmåder til vurdering af risikoen for brystcancer - Google Patents

Fremgangsmåder til vurdering af risikoen for brystcancer Download PDF

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DK2438193T3
DK2438193T3 DK10782820.4T DK10782820T DK2438193T3 DK 2438193 T3 DK2438193 T3 DK 2438193T3 DK 10782820 T DK10782820 T DK 10782820T DK 2438193 T3 DK2438193 T3 DK 2438193T3
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breast cancer
risk
single nucleotide
risk assessment
nucleotide polymorphisms
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David A Hinds
Bryan Walser
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Genetic Technologies Ltd
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    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
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    • C12Q2600/00—Oligonucleotides characterized by their use
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    • C12Q2600/112—Disease subtyping, staging or classification
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    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers
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    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/172—Haplotypes

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Claims (14)

1. Fremgangsmåde til vurdering af den samlede risiko for, at et humant kvindeligt individ udvikler en brystcancerfænotype, hvilken fremgangsmåde omfatter, at: der udføres en klinisk risikovurdering for det kvindelige individ; der udføres en genetisk risikovurdering for det kvindelige individ, hvor den genetiske risikovurdering omfatter, at der i en biologisk prøve, som stammer fra det kvindelige individ, detekteres tilstedeværelsen af mindst fem enkelte nukleotidpolymorfismer, som vides at være forbundet med en brystcancerfænotype, og som er valgt fra gruppen bestående af rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084, rs3817198, rs4973768, rs6504950 og rs11249433; og den kliniske risikovurdering kombineres med den genetiske risikovurdering for at opnå den samlede risiko for, at et humant kvindeligt individ udvikler en brystcancerfænotype, hvor de mindst fem enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042 og rs4415084.
2. Fremgangsmåde til bestemmelse af, om den samlede risiko for, at et humant kvindeligt individ udvikler en brystcancerfænotype, analyseret ved klinisk risikovurdering, bør omklassificeres, hvilken fremgangsmåde omfatter, at den kliniske risikovurdering kombineres med en genetisk risikovurdering for at opnå den samlede risiko for, at et humant kvindeligt individ udvikler en brystcancerfænotype, hvor den genetiske risikovurdering omfatter, at der i en biologisk prøve, som stammer fra det kvindelige individ, detekteres tilstedeværelsen af mindst fem enkelte nukleotidpolymorfismer, som vides at være forbundet med en brystcancerfænotype, og som er valgt fra gruppen bestående af rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084, rs3817198, rs4973768, rs6504950 og rs11249433; og det bestemmes, om en kombination af den kliniske risikovurdering med den genetiske risikovurdering resulterer i en omklassificering af individets samlede risiko for at udvikle en brystcancerfænotype, hvor de mindst fem enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042 og rs4415084.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor kombination af den kliniske risikovurdering med den genetiske risikovurdering omfatter, at risikovurderingerne multipliceres.
4. Fremgangsmåde ifølge krav 2 eller krav 3, hvor netto-omklassificeringsforbedringen (’’net reclassification improvement”, NRI) ved fremgangsmåden er større end 0,01 eller er større end 0,05.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 4, som har ét eller flere af følgende træk: i) udførelse af den kliniske risikovurdering anvender en model, som er valgt fra gruppen bestående af Gail-modellen, Claus-modellen, Claus-tabeller, BOADICEA, Jonker-modellen, Claus’ udvidede formel, Tyrer-Cuzick-model-len og Manchester-scoringssystemet, ii) udførelse af den kliniske risikovurdering omfatter, at der opnås information fra kvinden om én eller flere af følgende: medicinsk historie med brystcancer, duktalt carcinom eller lobulært carcinom, alder, alder ved første menstruationsperiode, alder ved den første fødsel, familiehistorie med brystcancer, resultater af tidligere brystbiopsier og race/etnicitet, iii) hvilket omfatter detektion af tilstedeværelsen af mindst seks, syv, otte, ni eller ti enkelte nukleotidpolymorfismer, som vides at være forbundet med en brystcancerfænotype, iv) de enkelte nukleotidpolymorfismer testes individuelt for forbindelse med brystcancer ved logistisk regression under en log-additiv model uden ko-variater, v) kvinden er kaukasisk, vi) kvinden har fået taget en biopsi af brystet, vii) resultaterne af den kliniske risikovurdering indikerer, at kvinden bør underkastes hyppigere screening og/eller profylaktisk anti-brystcancerterapi, og viii) hvis det bestemmes, at individet har risiko for at udvikle brystcancer, er det mere sandsynligt, at individet er modtageligt for østrogen-inhibering end ik-ke-modtageligt.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 5, som omfatter, at i) der detekteres mindst syv enkelte nukleotidpolymorfismer, hvor de enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084 og rs3817198, ii) der detekteres mindst syv enkelte nukleotidpolymorfismer, hvor de enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084 og rs3817198, iii) der detekteres mindst ti enkelte nukleotidpolymorfismer, hvor de enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084, rs3817198, rs4973768, rs6504950 og rs11249433, iv) der detekteres mindst ti enkelte nukleotidpolymorfismer, hvor de enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084, rs3817198, rs4973768, rs6504950 og rs11249433.
7. Fremgangsmåde ifølge krav 5 eller krav 6, hvor den kliniske risikovurdering anvender Gail-modellen.
8. Kit, som omfatter mindst fem sæt primere til amplifikation af fem eller flere nukleinsyrer, hvor de fem eller flere nukleinsyrer uafhængigt omfatter én af mindst fem enkelte nukleotidpolymorfismer, som er valgt fra gruppen bestående af rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084, rs3817198, rs4973768, rs6504950 og rs11249433, hvor de mindst fem enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042 og rs4415084.
9. Genetisk array, som omfatter mindst fem nukleinsyrer, som uafhængigt omfatter én af mindst fem enkelte nukleotidpolymorfismer, som er valgt fra gruppen bestående af rs2981582, rs3803662, rs889312, rs13387042, rs13281615, rs4415084, rs3817198, rs4973768, rs6504950 og rs11249433, hvor de mindst fem enkelte nukleotidpolymorfismer i det mindste omfatter rs2981582, rs3803662, rs889312, rs13387042 og rs4415084.
10. Fremgangsmåde til bestemmelse af behovet for rutinemæssig diagnostisk testning af et humant kvindeligt individ for brystcancer, hvilken fremgangsmåde omfatter vurdering af individets samlede risiko for at udvikle en brystcancerfænotype under anvendelse af en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7.
11. Fremgangsmåde til screening for brystcancer i et humant kvindeligt individ, hvilken fremgangsmåde omfatter vurdering af individets samlede risiko for at udvikle en brystcancerfænotype under anvendelse af en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7 og rutinemæssig screening for brystcancer i individet, hvis de vurderes til at have risiko for at udvikle brystcancer.
12. Fremgangsmåde til bestemmelse af behovet hos et humant kvindeligt individ for profylaktisk anti-brystcancerterapi, hvilken fremgangsmåde omfatter vurdering af individets samlede risiko for at udvikle en brystcancerfænotype under anvendelse af en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7.
13. Anti-brystcancerterapi til anvendelse til forebyggelse af brystcancer hos et humant kvindeligt individ, som har risiko derfor, hvor individet vurderes til at have risiko for at udvikle brystcancer ved en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7.
14. Fremgangsmåde til stratificering af en gruppe af humane kvindelige individer for et klinisk forsøg med en kandidatterapi, hvilken fremgangsmåde omfatter vurdering af individernes individuelle samlede risiko for at udvikle en brystcancerfænotype under anvendelse af en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 7 samt anvendelse af resultaterne af vurderingen til at udvælge individer, for hvilke det er mere sandsynligt, at de er modtagelige for terapien.
DK10782820.4T 2009-06-01 2010-06-01 Fremgangsmåder til vurdering af risikoen for brystcancer DK2438193T3 (da)

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US20180080089A1 (en) 2018-03-22
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CA2763500C (en) 2019-09-03
HK1168387A1 (en) 2012-12-28

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