# US 2019/0169701 A1 · Method of predicting effect of medicinal therapy on cancer > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0169701 A1 - Document ID: US20190169701A1 - Status: Published application - Kind: A1 - Application number: 16/308,210 - Filed: 2017-03-15 - Published: 2019-06-06 - Earliest claimed: 2016-06-10 - Assignees: National Cancer Center; Miraca Research Institute G.K. - Applicants: National Cancer Center; Miraca Research Institution G.K. - Inventors: Hirofumi MUKAI; Toshikazu USHIJIMA; Satoshi YAMASHITA - Web page: https://patentgrep.com/patent/US20190169701A1 ## CPC - C12Q 1/6883: for diseases caused by alterations of genetic material - C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575) - A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum - A61K 45/00: Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00 - A61P 35/00: Antineoplastic agents - C12Q 1/68: involving nucleic acids - G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor - G01N 33/575: for cancer - G01N 33/57515: of the breast - C12Q 2600/154: Methylation markers - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract The present invention provides a factor capable of predicting an effect of a medicinal therapy on a cancer such as HER2 positive cancer. More specifically, the present invention provides a method of predicting the effect of the medicinal therapy on the cancer, comprising: (1) analyzing a methylation level of a cytosine residue in one or more CpG sites present within a nucleotide sequence in a promotor region, an untranslated region or a translated region of HSD17B4 gene in a sample taken from a human subject; and (2) predicting the effect of the medicinal therapy on the cancer based on the analyzed methylation level. ## Claims ### Claim 1 A method of predicting an effect of a medicinal therapy on a cancer, the method comprising: analyzing a methylation level of a cytosine residue in one or more CpG sites present within a nucleotide sequence in a promotor region, an untranslated region or a translated region of HSD17B4 gene in a sample taken from a human subject; and predicting the effect of the medicinal therapy on the cancer based on the analyzed methylation level. ### Claim 2 (depends on 1) The method according to claim 1, wherein the sample taken from the human subject is at least one sample selected from the group consisting of a blood, a body fluid, a tissue, and a cell. ### Claim 3 (depends on 1) The method according to claim 1, wherein the CpG site is a CpG site normally present between positions 56 and 94 on the basis of a transcription start site. ### Claim 4 (depends on 3) The method according to claim 3, wherein the CpG site is a CpG site normally present at positions 92 and 93 on the basis of the transcription start site. ### Claim 5 (depends on 1) The method according to claim 1, wherein the cancer is a HER2-positive cancer. ### Claim 6 (depends on 1) The method according to claim 1, wherein the cancer is a breast cancer. ### Claim 7 (depends on 6) The method according to claim 6, further comprising measuring the expression of estrogen receptor in the sample. ### Claim 8 (depends on 1) The method according to claim 1, wherein the medicinal therapy is a treatment with a HER2 inhibitor. ### Claim 9 (depends on 8) The method according to claim 8, wherein the HER2 inhibitor is an antibody. ### Claim 10 (depends on 9) The method according to claim 9, wherein the antibody is trastuzumab. ### Claim 11 (depends on 1) The method according to claim 1, wherein the analyzing comprises analyzing with at least one means selected from the group consisting of bisulfite, primers, a nucleic acid probe, a restriction enzyme, an anti-methylated cytosine antibody, and a nanopore. ### Claim 12 (depends on 1) The method according to claim 1, wherein the analysis is performed by a bisulfite sequencing method, a bisulfite pyrosequencing method, a methylation specific PCR method, a restriction enzyme landmark genome scanning (RLGS) method, a single nucleotide primer extension (SNuPE) method, a CpG island microarray method, a MethyLight method, a COBRA method, a mass spectroscopy (mass array) method, use of a methylation specific restriction enzyme, a high resolution melting analysis (HRM) method, a nanopore analysis method, an ICON probe method, a methylation specific MLPA method, or an immunoassay. ### Claim 13 A diagnosis kit for an effect of a medicinal therapy on a cancer, the diagnosis kit comprising an analytical means for analyzing methylation of a cytosine residue in one or more CpG sites present within a nucleotide sequence in a promotor region, an untranslated region or a translated region of HSD17B4 gene. ### Claim 14 (depends on 13) The diagnosis kit according to claim 13, wherein the CpG site is a CpG site normally present between positions 56 and 94 on the basis of a transcription start site. ### Claim 15 (depends on 14) The diagnosis kit according to claim 14, wherein the CpG site is a CpG site normally present at positions 92 and 93 on the basis of the transcription start site. ### Claim 16 (depends on 13) The diagnosis kit according to claim 13, wherein the analytical means is at least one means selected from the group consisting of bisulfite, primers, a nucleic acid probe, a restriction enzyme, an anti-methylated cytosine antibody, and a nanopore. ### Claim 17 A medicinal therapy on a cancer, comprising: analyzing a methylation level of a cytosine residue in one or more CpG sites present within a nucleotide sequence in a promotor region, an untranslated region or a translated region of HSD17B4 gene in a sample taken from a human subject; and predicting an effect of the medicinal therapy on the cancer based on the analyzed methylation level; selecting a human predicted to receive the effect of the medicinal therapy on the cancer; and giving the medicinal therapy to the selected human. ### Claim 18 A method of selecting a treatment on a cancer, comprising: analyzing a methylation level of a cytosine residue in one or more CpG sites present within a nucleotide sequence in a promotor region, an untranslated region or a translated region of HSD17B4 gene in a sample taken from a human subject; and selecting the treatment on the cancer based on the analyzed methylation level.