HRP20191481T1 - Mikro-rnk biomarkeri za identificiranje rizika i/ili dijagnosticiranje tumora pluća - Google Patents

Mikro-rnk biomarkeri za identificiranje rizika i/ili dijagnosticiranje tumora pluća Download PDF

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HRP20191481T1
HRP20191481T1 HRP20191481T HRP20191481T1 HR P20191481 T1 HRP20191481 T1 HR P20191481T1 HR P20191481 T HRP20191481 T HR P20191481T HR P20191481 T1 HRP20191481 T1 HR P20191481T1
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mir
hsa
expression levels
mirna
biological sample
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Gabriella Sozzi
Ugo Pastorino
Mattia Boeri
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Gabriella Sozzi
Ugo Pastorino
Mattia Boeri
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Priority claimed from ITMI2011A000173A external-priority patent/IT1403685B1/it
Priority claimed from ITMI2011A000172A external-priority patent/IT1406672B1/it
Priority claimed from ITMI2011A000174A external-priority patent/IT1406866B1/it
Application filed by Gabriella Sozzi, Ugo Pastorino, Mattia Boeri filed Critical Gabriella Sozzi
Publication of HRP20191481T1 publication Critical patent/HRP20191481T1/hr

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16B—BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B30/00—ICT specially adapted for sequence analysis involving nucleotides or amino acids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/118—Prognosis of disease development
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/158—Expression markers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/178—Oligonucleotides characterized by their use miRNA, siRNA or ncRNA

Claims (15)

1. Metoda za određivanje aktualnog prisustva tumora pluća kod osobe ili subjekta koji ima rizik za tumor pluća, naznačena time, što uključuje: određivanje razina ekspresije miRNK hsa-miR-660, hsa-miR-197 i hsa-miR- 92a u biološkom uzorku uzetom od subjekta, gdje je biološki uzorak cijela krv, frakcija krvi, plazma ili serum; izračunavanje odnosa između razina ekspresije parova miRNK hsa-miR-197/hsa-miR-92a i hsa-miR-197/hsa-miR-660; uspoređivanje svakog od odnosa s respektivnim kontrolnim odnosom predstavljenim odnosima razina ekspresije parova miRNK dobivenih iz kontrolnog biološkog uzorka uzetog od subjekta koji nema bolest, i određivanje koji od odnosa odstupa od respektivnih kontrolnih vrijednosti; pri čemu se osoba definira kao da ima tumor pluća ili ima rizik za tumor pluća ako 100% odnosa odstupa u odnosu na respektivne kontrolne vrijednosti.
2. Metoda u skladu s patentnim zahtjevom 1, metoda za određivanje aktualnog prisustva tumora pluća kod osobe, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-106a; i izračunavanje odnosa između razina ekspresije parova miRNK hsa-miR- 106a/hsa-miR-92a, hsa-miR-106a/hsa-miR-660 i hsa-miR-106a/hsa-miR-197.
3. Metoda u skladu s patentnim zahtjevom 2, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-142-3p, hsa-miR-28-3 i hsa- miR-140-5; i izračunavanje odnosa između razina ekspresije parova miRNK hsa-miR-140-5p/hsa-miR-197, hsa-miR-140-5p/hsa-miR-28-3p, hsa-miR-142-3p/hsa-miR-197, hsa-miR-142-3p/hsa-miR-28-3p, hsa-miR-28-3p/hsamiR-660 i hsa-miR- 28-3 p/hsa-miR-92a.
4. Metoda u skladu s patentnim zahtjevom 3, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-17, hsa-miR-19b, hsa-miR-101, hsa-miR-145, hsamiR-320, hsa-miR-126 i hsa-miR-148a; i izračunavanje odnosa između razina ekspresije parova miRNK hsa-miR-101/hsa-miR-660, hsa-miR-101/hsa-miR-92a, hsa-miR-106a/hsa-miR-320, hsa-miR-126/hsa-miR-660, hsa-miR-126/hsa-miR-92a, hsa-miR-142-3p/hsa-miR-145, hsa-miR-145/hsa-miR-660, hsa-miR-145/hsa-miR-92a, hsa-miR-148a/hsa-miR-660, hsa-miR-148a/hsa-miR-92a, hsa-miR-17/hsa-miR-320, hsa-miR-17/hsa-miR-660, hsa-miR-17/hsa-miR-92a, hsa-miR-197/hsa-miR-320, hsa-miR-19b/hsa-miR-660, hsa-miR-19b/hsa-miR-92a.
5. Metoda u skladu s patentnim zahtjevom 1, metoda za određivanje subjekta koji ima rizik za tumor pluća, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-17, hsa-miR-451, hsa-miR-19b, hsa-miR-106a, hsamiR-101, hsa-miR-97, hsa-miR-133a, hsa-miR-16, hsa-miR-140-3p, hsa-miR-15b, hsa-miR-142-3p, hsa-miR-126, hsa-miR-28-3p i hsa-miR-320; i izračunavanje većeg broja odnosa između razina ekspresije parova miRNK hsa-miR-17/hsa-miR-660, hsa-miR-17/hsa-miR-92a, hsa-miR-197/hsa-miR-451, hsa-miR-17/hsa-miR-451, hsa-miR-19b/hsa-miR-660, hsa-miR-197/hsa-miR-19b, hsa-miR-19b/hsa-miR-451, hsa-miR-106a/hsa-miR-660, hsa-miR-106a/hsa-miR-451, hsa-miR-106a/hsa-miR-92a, hsa-miR-101/hsa-miR-97, hsa-miR-101/hsa-miR-17, hsa-miR-133a/hsamiR-660, hsa-miR-133a/hsa-miR-451, hsa-miR-101/hsa-miR-133a, hsa-miR-16/hsa-miR-660, hsa-miR-16/hsa-miR-451, hsa-miR-140-3p/hsa-miR-660, hsa-miR-101/hsa-miR-140-3p, hsa-miR-15b/hsa-miR-451, hsa-miR-15b/hsa-miR-660, hsa-miR-142-3p/hsa-miR-15b, hsa-miR-126/hsa-miR-660, hsa-miR-28-3p/hsamiR-660 i hsa-miR-320/hsa-miR-660.
6. Metoda u skladu s patentnim zahtjevom 1, naznačena time, što navedeni tumor ne može biti detektiran spiralnim CT skeniranjem ili gdje navedeno određivanje prisustva navedenog tumora potvrđuje detekciju spiralnim CT skeniranjem.
7. Metoda za određivanje aktualnog prisustva agresivnog tumora pluća kod osobe, naznačena time, što uključuje: određivanje razina ekspresije miRNK hsa-miR-197, hsa-miR-451 i hsa-miR- 486-5p u biološkom uzorku uzetom od subjekta, gdje je biološki uzorak cijela krv, frakcija krvi, plazma ili serum; izračunavanje većeg broja odnosa između razina ekspresije parova miRNK hsa-miR-197/hsa-miR-451 i hsa-miR-197/hsa-miR-486-5p; uspoređivanje svakog od odnosa s respektivnim kontrolnim odnosom predstavljenim odnosima razina ekspresije parova miRNK dobivenih iz kontrolnog biološkog uzorka uzetog od subjekta koji nema bolest, i određivanje koji od odnosa odstupa od respektivnih kontrolnih vrijednosti; pri čemu se osoba definira kao da ima agresivni tumor pluća ako 100% odnosa odstupa u odnosu na respektivne kontrolne vrijednosti.
8. Metoda iz patentnog zahtjeva 6, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-106a, hsa-miR-17, hsa-miR-126, hsa-miR-660, hsamiR-28-3p, hsa-miR-19b, hsa-miR-140-5p, hsa-miR-16, hsa-miR-92a, hsa-miR-101, hsa-miR-145, hsa-miR-148a, hsa-miR-142-3p, hsa-miR-30b, hsa-miR-15b, hsa-miR-30e i hsa-miR-21 u biološkom uzorku uzetom od subjekta, gdje je biološki uzorak cijela krv, frakcija krvi, plazma ili serum; izračunavanje većeg broja odnosa između razina ekspresije parova miRNK hsa-miR-106a/hsa-miR-197, hsa-miR-106a/hsa-miR-451, hsa-miR-106a/hsa-miR-486-5p, hsa-miR-126/hsa-miR-197, hsa-miR-126/hsamiR-451, hsa-miR-126/hsa-miR-486-5p, hsa-miR-17/ hsa-miR-197, hsa-miR-17/hsa-miR-451, hsa-miR-17/hsa-miR-486-5p, hsa-miR-101/hsa-miR-197, hsa-miR-126/hsa-miR-660, hsa-miR-140-5p/hsa-miR-197, hsamiR-140-5p/hsa-miR-28-3p, hsa-miR-142-3p/hsa-miR-197, hsa-miR-145/hsa-miR-451, hsa-miR-148a/hsamiR-451, hsa-miR-15b/hsa-miR-451, hsa-miR-16/hsa-miR-197, hsa-miR-197/hsa-miR-19b, hsa-miR-197/hsa-miR-21, hsa-miR-197/hsa-miR-660, hsa-miR-197/hsa-miR-92a, hsa-miR-19b/hsa-miR-451, hsa-miR-19b/hsa-miR-486-5p, hsa-miR-19b/hsa-miR-660, hsa-miR-28-3p/hsa-miR-451, hsa-miR-28-3p/hsa-miR-486-5p, hsa-miR-28-3p/hsa-miR-660, hsa-miR-30b/hsa-miR-451 i hsa-miR-30c/ hsa-miR-451.
9. Metoda za određivanje aktualnog prisustva agresivnog tumora pluća kod osobe, naznačena time, što uključuje: određivanje razina ekspresije miRNK hsa-miR-660, hsa-miR-142-3p, hsa-miR-19b, hsa-miR-486-5p, hsa-miR-21 i hsa-miR-221 u biološkom uzorku uzetom od subjekta, gdje je biološki uzorak cijela krv, frakcija krvi, plazma ili serum; izračunavanje većeg broja odnosa između razina ekspresije parova miRNK hsa-miR-142-3p/hsa-miR-19b, hsa-miR-142-3p/hsa-miR-486-5p, hsa-miR-19b/hsa-miR-21, hsa-miR-19b/hsa-miR-221, hsa-miR-21/hsa-miR-486-5p, hsa-miR-21/hsa-miR-660, hsa-miR-221/hsa-miR-486-5p, hsa-miR-221/hsa-miR-660 i hsa-miR-142-3p/hsa-miR-660; uspoređivanje svakog od odnosa s respektivnim kontrolnim odnosom predstavljenim odnosima razina ekspresije parova miRNK dobivenih iz kontrolnog biološkog uzorka uzetog od subjekta koji nema bolest, i određivanje koji od odnosa odstupa od respektivnih kontrolnih vrijednosti; pri čemu se osoba definira kao da ima agresivni tumor pluća ako 100% odnosa odstupa u odnosu na respektivne kontrolne vrijednosti.
10. Metoda u skladu s patentnim zahtjevom 9, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-148a, hsa-miR-15b, hsa-miR-30b i hsa-miR-16; i izračunavanje odnosa između razina ekspresije parova miRNK hsa-miR-148a/hsa-miR-19b, hsa-miR-148a/hsa-miR-486-5p, hsa-miR-15b/hsa-miR-19b, hsa-miR-15b/hsa-miR-486-5p, hsa-miR-16/hsa-miR-486-5p, hsa-miR-19b/hsa-miR-30b i hsa-miR-30b/hsa-miR-486-5p.
11. Metoda određivanja subjekta koji ima rizik za agresivni tumor pluća, naznačena time, što uključuje: određivanje razina ekspresije miRNK miRNK hsa-miR-197, hsa-miR-101 i hsa-miR-451 u biološkom uzorku uzetom od subjekta, gdje je biološki uzorak cijela krv, frakcija krvi, plazma ili serum; izračunavanje odnosa između razina ekspresije parova miRNK hsa-miR-101/hsa-miR-197 i hsa-miR-197/hsa-miR-451; uspoređivanje svakog od odnosa s respektivnim kontrolnim odnosom predstavljenim odnosima razina ekspresije parova miRNK dobivenih iz kontrolnog biološkog uzorka uzetog od subjekta koji nema bolest, i određivanje koji od odnosa odstupa od respektivnih kontrolnih vrijednosti; pri čemu osoba ima rizik za agresivni tumor pluća ako 100% odnosa odstupa u odnosu na respektivne kontrolne vrijednosti.
12. Metoda iz patentnog zahtjeva 11, naznačena time, što uključuje još i: određivanje razina ekspresije miRNK hsa-miR-28-3p, hsa-miR-21, hsa-miR-106a, hsa-miR-16, hsamiR-17, hsa-miR-92a, hsa-miR-30e, hsa-miR-320, hsa-miR-221, hsa-miR-145, hsa-miR-30b, hsa-miR-19b, hsa-miR-126, hsa-miR-15b, hsa-miR-148a i hsa-miR-140-3p; i izračunavanje većeg broja odnosa između razina ekspresije parova miRNK hsa-miR-101/hsa-miR-28-3p, hsa-miR-28-3p/hsa-miR-451, hsa-miR-197/hsa-miR-21, hsa-miR-21/hsa-miR-28-3p, hsa-miR-101/hsa-miR-106a, hsa-miR-106a/hsa-miR-451, hsa-miR-106a/hsa-miR-21, hsa-miR-16/hsa-miR-28-3p, hsa-miR-16/hsamiR-197, hsa-miR-106a/hsa-miR-16, hsa-miR-101/hsa-miR-17, hsa-miR-17/hsa-miR-451, hsa-miR-17/hsamiR-21, hsa-miR-16/hsa-miR-17, hsa-miR-28-3p/hsa-miR-92a, hsa-miR-197/hsa-miR-92a, hsa-miR-197/hsamiR-30c, hsa-miR-28-3p/hsa-miR-30c, hsa-miR-320/hsa-miR-92a, hsa-miR-320/hsa-miR-451, hsa-miR-221/hsa-miR-451, hsa-miR-21/hsa-miR-221, hsa-miR-145/hsa-miR-197, hsa-miR-145/hsa-miR-28-3p, hsamiR-28-3p/hsa-miR-30b, hsa-miR-197/hsa-miR-30b, hsa-miR-19b/hsa-miR-451, hsa-miR-126/hsa-miR-451, hsa-miR-15b/hsa-miR-451, hsa-miR-148a/hsa-miR-197 i hsa-miR-140-3p/hsa-miR-451.
13. Metoda iz bilo kojeg od prethodnih patentnih zahtjeva, naznačena time, što je mikrocelurarni karcinom pluća (SCLC), rak pluća ne-malih stanica (NSCLC), adenokarcinom pluća (ADC), bronhoalveolami karcinom (BAC), plućni karcinom skvamoznih stanica (SCC) ili karcinom velikih stanica (LC).
14. Metoda iz bilo kojeg od prethodnih patentnih zahtjeva, naznačena time, što je biološki uzorak porijeklom od osobe koja je pušač, koja u momentu uzimanja uzorka ne prikazuje tumor pluća ako se podvrgne dijagnostičkim metodama vizualizacije, preciznije, osobe koja je pušač, koja ne prikazuje nodule dimenzija preko 5 mm ako se podvrgne spiralnom CT skeniranju.
15. Metoda iz bilo kojeg od prethodnih patentnih zahtjeva, naznačena time, što se navedeni kontrolni biološki uzorak uzima od navedenog subjekta do tri godine prije dijagnoze.
HRP20191481 2011-02-07 2019-08-16 Mikro-rnk biomarkeri za identificiranje rizika i/ili dijagnosticiranje tumora pluća HRP20191481T1 (hr)

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ITMI2011A000173A IT1403685B1 (it) 2011-02-07 2011-02-07 Procedimento ed apparecchiatura per identificare individui a rischio di tumore polmonare e/o per diagnosticare un tumore polmonare, nonche' composizione e metodo per ridurre o eliminare il rischio di tumore polmonare.
ITMI2011A000172A IT1406672B1 (it) 2011-02-07 2011-02-07 Procedimento ed apparecchiatura per identificare individui a rischio di tumore polmonare e/o per diagnosticare un tumore polmonare, nonche' composizione e metodo per ridurre o eliminare il rischio di tumore polmonare.
ITMI2011A000174A IT1406866B1 (it) 2011-02-07 2011-02-07 Procedimento ed apparecchiatura per identificare individui a rischio di tumore polmonare e/o per diagnosticare un tumore polmonare, nonché composizione e metodo per ridurre o eliminare il rischio di tumore polmonare
US201161522328P 2011-08-11 2011-08-11
EP12720568.0A EP2734636B1 (en) 2011-02-07 2012-02-07 Micro-rna biomarkers for identifying risk of and/or for diagnosing lung tumour
PCT/IB2012/000567 WO2012107841A2 (en) 2011-02-07 2012-02-07 Micro-rna biomarkers and methods of using same

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