Use of long non-coding rna for the diagnosis of prostate cancer

Patent metadata

Field	Value
Publication number	US-2021381059-A1
Application number	US-201917287132-A
Country	US
Kind code	A1
Filing date	Oct 24, 2019
Priority date	Oct 25, 2018
Publication date	Dec 9, 2021
Grant date	—

Abstract

The present invention provides long noncoding RNAs (lncRNAs) that allow to diagnose prostate cancer much more accurately than the existent non-invasive diagnostic tools. So, this invention relates to the use of at least one of these lncRNA or a combination thereof as a diagnosis marker for prostate cancer. It also relates to an in vitro method for prostate cancer diagnosis of a subject as well as to a kit for performing this method.

First claim

1 - 16 . (canceled)

17 . An in vitro method for prostate cancer diagnosis of a subject, wherein the method comprises the step of determining the amount of at least one biomarker in a biological sample from said subject, said at least one biomarker being selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22 and any fragment thereof of at least 30 nucleotides, and wherein an increased amount of the at least one biomarker is indicative of prostate cancer.

18 . The method according to claim 17 , wherein the at least one biomarker is selected the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 20, SEQ ID NO: 21 and any fragment thereof of at least 30 nucleotides.

19 . The method according to claim 17 , wherein the at least one biomarker is used in combination with at least one additional biomarker selecting from the group consisting of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 23, SEQ ID NO: 24 and any fragment thereof of at least 30 nucleotides.

20 . The method according to claim 17 , wherein at least three, four, five, six, seven or eight biomarkers are used in combination and wherein said combination are selected in any one of the following groups consisting of:
SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 10, SEQ ID NO: 11 and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 10, SEQ ID NO: 14 and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 14, and a fragment of at least 30 nucleotides thereof; and SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 14 and a fragment of at least 30 nucleotides thereof.

21 . The method according to claim 17 , wherein the combination comprises or consists of any one of the following combinations of biomarkers:
SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 10, SEQ ID NO: 11 and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 10, SEQ ID NO: 14 and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 14, and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10 and a fragment of at least 30 nucleotides thereof; or SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 14 and a fragment of at least 30 nucleotides thereof.

22 . The method according to claim 21 , wherein the combination further comprises one, two, three or four biomarkers selected in the group consisting of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO:17, SEQ ID NO: 19 and any fragment of at least 30 nucleotides thereof.

23 . The method according to claim 22 , wherein the combination comprises or consists of the following combinations of biomarkers:
SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 19 and a fragment of at least 30 nucleotides thereof, and optionally SEQ ID NO: 22 or a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 10, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 19 and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 19 and a fragment of at least 30 nucleotides thereof, and optionally SEQ ID NO: 22 and/or SEQ ID NO: 23 and/or SEQ ID NO: 24 or a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 19 and a fragment of at least 30 nucleotides thereof; SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 19 and a fragment of at least 30 nucleotides thereof; or SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 10, SEQ ID NO: 15, and SEQ ID NO: 16 and a fragment of at least 30 nucleotides thereof.

24 . The method according to claim 17 , said method discriminating high- and intermediate-risk of developing a prostate cancer versus low-risk of developing a prostate cancer in a subject.

25 . The method according to claim 17 , wherein said sample is a body fluid, blood sample or urine sample.

26 . The method according to claim 17 , wherein the biomarker amount is determined by amplification or by hybridization.

27 . The method according to claim 17 , wherein the subject is a mammal, a human, or a man of at least 40 years old.

28 . A kit for the diagnosis of prostate cancer in a subject, wherein the kit comprises (i) probes and/or primers capable to specifically hybridize to at least one biomarker selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 20 and SEQ ID NO: 21; and optionally, a leaflet providing guidelines to use said kit.

29 . The kit according to claim 28 , wherein the kit further comprises probes and/or primers for the detection of additional prostate cancer biomarkers and/or primers capable to specifically hybridize to at least one biomarker selected from the group consisting of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24.

30 . An isolated nucleic acid comprising or consisting of a sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 20 and SEQ ID NO: 21 and any fragment thereof of at least 30 nucleotides or a complementary sequence thereof, wherein the nucleic acid sequence has a length shorter than 3500 nucleotides.

Assignees

• Inst Curie
• Centre Nat Rech Scient
• Univ Paris Saclay
• Univ Sorbonne

Inventors

• Morillon Antonin
• Gautheret Daniel
• Pinskaya Marina

Classifications

• C12Q2600/158

  Expression markers · CPC title

• C12Q1/6886 Primary

  for cancer (immunoassay for cancer G01N33/575) · CPC title

• C12Q2600/118

  Prognosis of disease development · CPC title