EP-4737595-A2 - KIT, DEVICE, AND METHOD FOR DETECTING OVARIAN TUMOR
Abstract
This application provides a kit or a device for detection of ovarian tumor, comprising a nucleic acid(s) for detecting a miRNA(s) in a sample from a subject, and a method for detecting ovarian tumor, comprising measuring the miRNA(s) in vitro.
Inventors
- KIDA, Yuho
- KOZONO, SATOKO
- SUDO, HIROKO
- KONDOU, SATOSHI
- KAWAUCHI, JUNPEI
- NOBUMASA, HITOSHI
- OCHIYA, TAKAHIRO
- KATO, TOMOYASU
Assignees
- Toray Industries, Inc.
- National Cancer Center
Dates
- Publication Date
- 20260506
- Application Date
- 20180427
Claims (16)
- Use of a kit in in vitro detection or diagnosis of ovarian tumor in a sample from a subject, wherein the kit comprises a nucleic acid(s) capable of specifically binding to a polynucleotide of ovarian tumor marker: miR-1233-5p, or to a complementary strand of the polynucleotide, wherein the sample is blood, serum or plasma.
- Use of a device in in vitro detection or diagnosis of ovarian tumor in a sample from a subject, wherein the device comprises a nucleic acid(s) capable of specifically binding to a polynucleotide of ovarian tumor marker: miR-1233-5p, or to a complementary strand of the polynucleotide, wherein the sample is blood, serum, or plasma.
- The use according to claim 1 or 2, wherein the nucleic acid(s) is/are a polynucleotide(s) selected from the group consisting of the following polynucleotides (a) to (e): (a) a polynucleotide consisting of a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (b) a polynucleotide comprising a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t; (c) a polynucleotide consisting of a nucleotide sequence complementary to a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (d) a polynucleotide comprising a nucleotide sequence complementary to a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t; and (e) a polynucleotide hybridizing under stringent conditions to any of the polynucleotides (a) to (d).
- The use according to any one of claims 1 to 3, wherein the kit or device further comprises a nucleic acid(s) capable of specifically binding to at least one polynucleotide selected from the following other ovarian tumor markers: miR-4675, miR-4783-3p, miR-1228-5p, miR-4532, miR-6802-5p, miR-6784-5p, miR-3940-5p, miR-1307-3p, miR-8073, miR-3184-5p, miR-6088, miR-5195-3p, miR-320b, miR-4649-5p, miR-6800-5p, miR-1343-3p, miR-4730, miR-6885-5p, miR-5100, miR-1203, miR-6756-5p, miR-373-5p, miR-1268a, miR-1260b, miR-4258, miR-4697-5p, miR-1469, miR-4515, miR-6861-5p, miR-6821-5p, miR-575, miR-6805-5p, miR-4758-5p, miR-3663-3p, miR-4530, miR-6798-5p, miR-6781-5p, miR-885-3p, miR-1273g-3p, miR-4787-3p, miR-4454, miR-4706, miR-1249-3p, miR-887-3p, miR-6786-5p, miR-1238-5p, miR-6749-5p, miR-6729-5p, miR-6825-5p, miR-663b, miR-6858-5p, miR-4690-5p, miR-6765-5p, miR-4710, miR-6775-5p, miR-371a-5p, miR-6816-5p, miR-296-3p, miR-7977, miR-8069, miR-6515-3p, miR-4687-5p, miR-1343-5p, miR-7110-5p, miR-4525, miR-3158-5p, miR-6787-5p, miR-614, miR-4689, miR-1268b, miR-1228-3p, miR-1185-1-3p, miR-940, miR-939-5p, miR-6757-5p, miR-1275, miR-5001-5p, miR-6826-5p, miR-6765-3p, miR-3679-3p, miR-4718, miR-4286, miR-8059, miR-4447, miR-4448, miR-658, miR-6766-3p, miR-197-5p, miR-6887-5p, miR-6742-5p, miR-6729-3p, miR-5090, miR-7975, miR-4505, miR-6889-5p, miR-4708-3p, miR-6131, miR-1225-3p, miR-6132, miR-4734, miR-3194-3p, miR-638, miR-2467-3p, miR-4728-5p, miR-5572, miR-6789-5p, miR-8063, miR-4429, miR-6840-3p, miR-4476, miR-675-5p, miR-711, miR-6875-5p, miR-3160-5p, miR-1908-5p, miR-6726-5p, miR-1913, miR-8071, miR-3648, miR-4732-5p, miR-4787-5p, miR-3917, miR-619-5p, miR-1231, miR-342-5p, miR-4433a-5p, miR-6766-5p, miR-4707-5p, miR-7114-5p, miR-6872-3p, miR-6780b-5p, miR-7845-5p, miR-6798-3p, miR-665, miR-6848-5p, miR-5008-5p, miR-4294, miR-6511a-5p, miR-4435, miR-4747-3p, miR-6880-3p, miR-6869-5p, miR-7150, miR-1260a, miR-6877-5p, miR-6721-5p, miR-4656, miR-1229-5p, miR-4433a-3p, miR-4274, miR-4419b, miR-4674, miR-6893-5p, miR-6763-3p, miR-6762-5p, miR-6738-5p, miR-4513, miR-6746-5p, miR-6880-5p, miR-4736, miR-718, miR-6717-5p, miR-7847-3p, miR-760, miR-1199-5p, miR-6813-5p, miR-6769a-5p, miR-1193, miR-7108-3p, miR-6741-5p, miR-4298, miR-6796-3p, miR-4750-5p, miR-6785-5p, miR-1292-3p, miR-4749-3p, miR-6800-3p, miR-4722-5p, miR-4746-3p, miR-4450, miR-6795-5p, miR-365a-5p, miR-498, miR-6797-5p, miR-1470, miR-6851-5p, miR-1247-3p, miR-5196-5p, miR-208a-5p, miR-6842-5p, miR-150-3p, miR-4534, miR-3135b, miR-3131, miR-4792, miR-6510-5p, miR-504-3p, miR-3619-3p, miR-671-5p, miR-4667-5p, miR-4430, miR-3195, miR-3679-5p, miR-6076, miR-6515-5p, miR-6820-5p, miR-4634, miR-187-5p, miR-6763-5p, miR-1908-3p, miR-1181, miR-6782-5p, miR-5010-5p, miR-6870-5p, miR-6124, miR-1249-5p, miR-6511b-5p, miR-1254, miR-4727-3p, miR-4259, miR-4771, miR-3622a-5p, miR-4480, miR-4740-5p, miR-6777-5p, miR-6794-5p, miR-4687-3p, miR-6743-5p, miR-6771-5p, miR-3141, miR-3162-5p, miR-4271, miR-1227-5p, miR-4257, miR-4270, miR-4516, miR-4651, miR-4725-3p, miR-6125, miR-6732-5p, miR-6791-5p, miR-6819-5p, miR-6891-5p, miR-7108-5p, miR-7109-5p, miR-642b-3p, and miR-642a-3p and/or miR-320a, miR-663a, miR-328-5p, miR-128-2-5p, miR-125a-3p, miR-191-5p, miR-92b-5p, miR-296-5p, miR-1246, miR-92a-2-5p, miR-128-1-5p, miR-1290, miR-211-3p, miR-744-5p, miR-135a-3p, miR-451a, miR-625-3p, miR-92a-3p, miR-422a, miR-483-5p, miR-652-5p, miR-24-3p, miR-23b-3p, miR-23a-3p, miR-92b-3p, and miR-22-3p, or to a complementary strand of the polynucleotide.
- The use according to claim 4, wherein the nucleic acid(s) is/are a polynucleotide(s) selected from the group consisting of the following polynucleotides (f) to (j): (f) a polynucleotide consisting of a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (g) a polynucleotide comprising a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275; (h) a polynucleotide consisting of a nucleotide sequence complementary to a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (i) a polynucleotide comprising a nucleotide sequence complementary to a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t; and (j) a polynucleotide hybridizing under stringent conditions to any of the polynucleotides (f) to (i).
- The use according to any one of claims 2 to 5, wherein the device is a device for measurement by a hybridization technique.
- The use according to claim 6, wherein the hybridization technique is a nucleic acid array technique.
- A method for detecting an ovarian tumor, comprising: measuring an expression level(s) of a target nucleic acid(s) of the following ovarian tumor marker: miR-1233-5p, in a sample obtained from a subject using a nucleic acid(s) capable of specifically binding to a polynucleotide of the ovarian tumor marker or to a complementary strand of the polynucleotide; and evaluating in vitro whether or not the subject has ovarian tumor using the measured expression level(s), wherein the sample is blood, serum, or plasma.
- A method for detecting an ovarian tumor, comprising: measuring an expression level(s) of a target nucleic acid(s) in a sample obtained from a subject using a kit defined in any one of claims 1, 3 to 5 or a device defined in any one of claims 2 to 7, comprising a nucleic acid(s) capable of specifically binding to the following ovarian tumor marker: miR-1233-5p, or to a complementary strand(s) of the polynucleotide; and evaluating in vitro whether or not the subject has ovarian tumor using both of the measured expression level(s) and a control expression level(s) from a healthy subject measured in the same way, wherein the sample is blood, serum, or plasma.
- A method for detecting an ovarian tumor, comprising: measuring an expression level(s) of a target nucleic acid in a sample obtained from a subject using a kit defined in any one of claims 1, 3 or 5 or a device defined in any one of claims 2 to 7, comprising a nucleic acid(s) capable of specifically binding to the following ovarian tumor marker: miR-1233-5p, or to a complementary strand of the polynucleotide; and assigning the expression level(s) of the target nucleic acid in the sample from the subject to a discriminant, which is capable of discriminatorily determining the presence or absence of ovarian tumor and is prepared with gene expression levels in a sample(s) from a subject(s) known to have ovarian tumor and a sample(s) from a subject(s) without ovarian tumor as a training sample(s), and thereby evaluating in vitro the presence or absence of ovarian tumor, wherein the sample is blood, serum, or plasma.
- The method according to any one of claims 8 to 10, wherein the nucleic acid(s) is/are a polynucleotide(s) selected from the group consisting of the following polynucleotides (a) to (e): (a) a polynucleotide consisting of a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (b) a polynucleotide comprising a nucleotide sequence represented by SEQ ID NO: 11; (c) a polynucleotide consisting of a nucleotide sequence complementary to a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (d) a polynucleotide comprising a nucleotide sequence complementary to a nucleotide sequence represented by SEQ ID NO: 11 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t; and (e) a polynucleotide hybridizing under stringent conditions to any of the polynucleotides (a) to (d).
- The method according to any one of claims 8 to 11, wherein the method further comprises measuring an expression level(s) of other target nucleic acid(s) using kit or device further comprising a nucleic acid(s) capable of specifically binding to at least one polynucleotide selected from the following other ovarian tumor markers: miR-4675, miR-4783-3p, miR-1228-5p, miR-4532, miR-6802-5p, miR-6784-5p, miR-3940-5p, miR-1307-3p, miR-8073, miR-3184-5p, miR-6088, miR-5195-3p, miR-320b, miR-4649-5p, miR-6800-5p, miR-1343-3p, miR-4730, miR-6885-5p, miR-5100, miR-1203, miR-6756-5p, miR-373-5p, miR-1268a, miR-1260b, miR-4258, miR-4697-5p, miR-1469, miR-4515, miR-6861-5p, miR-6821-5p, miR-575, miR-6805-5p, miR-4758-5p, miR-3663-3p, miR-4530, miR-6798-5p, miR-6781-5p, miR-885-3p, miR-1273g-3p, miR-4787-3p, miR-4454, miR-4706, miR-1249-3p, miR-887-3p, miR-6786-5p, miR-1238-5p, miR-6749-5p, miR-6729-5p, miR-6825-5p, miR-663b, miR-6858-5p, miR-4690-5p, miR-6765-5p, miR-4710, miR-6775-5p, miR-371a-5p, miR-6816-5p, miR-296-3p, miR-7977, miR-8069, miR-6515-3p, miR-4687-5p, miR-1343-5p, miR-7110-5p, miR-4525, miR-3158-5p, miR-6787-5p, miR-614, miR-4689, miR-1268b, miR-1228-3p, miR-1185-1-3p, miR-940, miR-939-5p, miR-6757-5p, miR-1275, miR-5001-5p, miR-6826-5p, miR-6765-3p, miR-3679-3p, miR-4718, miR-4286, miR-8059, miR-4447, miR-4448, miR-658, miR-6766-3p, miR-197-5p, miR-6887-5p, miR-6742-5p, miR-6729-3p, miR-5090, miR-7975, miR-4505, miR-6889-5p, miR-4708-3p, miR-6131, miR-1225-3p, miR-6132, miR-4734, miR-3194-3p, miR-638, miR-2467-3p, miR-4728-5p, miR-5572, miR-6789-5p, miR-8063, miR-4429, miR-6840-3p, miR-4476, miR-675-5p, miR-711, miR-6875-5p, miR-3160-5p, miR-1908-5p, miR-6726-5p, miR-1913, miR-8071, miR-3648, miR-4732-5p, miR-4787-5p, miR-3917, miR-619-5p, miR-1231, miR-342-5p, miR-4433a-5p, miR-6766-5p, miR-4707-5p, miR-7114-5p, miR-6872-3p, miR-6780b-5p, miR-7845-5p, miR-6798-3p, miR-665, miR-6848-5p, miR-5008-5p, miR-4294, miR-6511a-5p, miR-4435, miR-4747-3p, miR-6880-3p, miR-6869-5p, miR-7150, miR-1260a, miR-6877-5p, miR-6721-5p, miR-4656, miR-1229-5p, miR-4433a-3p, miR-4274, miR-4419b, miR-4674, miR-6893-5p, miR-6763-3p, miR-6762-5p, miR-6738-5p, miR-4513, miR-6746-5p, miR-6880-5p, miR-4736, miR-718, miR-6717-5p, miR-7847-3p, miR-760, miR-1199-5p, miR-6813-5p, miR-6769a-5p, miR-1193, miR-7108-3p, miR-6741-5p, miR-4298, miR-6796-3p, miR-4750-5p, miR-6785-5p, miR-1292-3p, miR-4749-3p, miR-6800-3p, miR-4722-5p, miR-4746-3p, miR-4450, miR-6795-5p, miR-365a-5p, miR-498, miR-6797-5p, miR-1470, miR-6851-5p, miR-1247-3p, miR-5196-5p, miR-208a-5p, miR-6842-5p, miR-150-3p, miR-4534, miR-3135b, miR-3131, miR-4792, miR-6510-5p, miR-504-3p, miR-3619-3p, miR-671-5p, miR-4667-5p, miR-4430, miR-3195, miR-3679-5p, miR-6076, miR-6515-5p, miR-6820-5p, miR-4634, miR-187-5p, miR-6763-5p, miR-1908-3p, miR-1181, miR-6782-5p, miR-5010-5p, miR-6870-5p, miR-6124, miR-1249-5p, miR-6511b-5p, miR-1254, miR-4727-3p, miR-4259, miR-4771, miR-3622a-5p, miR-4480, miR-4740-5p, miR-6777-5p, miR-6794-5p, miR-4687-3p, miR-6743-5p, miR-6771-5p, miR-3141, miR-3162-5p, miR-4271, miR-1227-5p, miR-4257, miR-4270, miR-4516, miR-4651, miR-4725-3p, miR-6125, miR-6732-5p, miR-6791-5p, miR-6819-5p, miR-6891-5p, miR-7108-5p, miR-7109-5p, miR-642b-3p, and miR-642a-3p, and/or miR-320a, miR-663a, miR-328-5p, miR-128-2-5p, miR-125a-3p, miR-191-5p, miR-92b-5p, miR-296-5p, miR-1246, miR-92a-2-5p, miR-128-1-5p, miR-1290, miR-211-3p, miR-744-5p, miR-135a-3p, miR-451a, miR-625-3p, miR-92a-3p, miR-422a, miR-483-5p, miR-652-5p, miR-24-3p, miR-23b-3p, miR-23a-3p, miR-92b-3p, and miR-22-3p, or to a complementary strand of the polynucleotide.
- The method according to claim 12, wherein the nucleic acid(s) is/are a polynucleotide(s) selected from the group consisting of the following polynucleotides (f) to (j): (f) a polynucleotide consisting of a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (g) a polynucleotide comprising a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275; (h) a polynucleotide consisting of a nucleotide sequence complementary to a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t, a variant thereof, a derivative thereof, or a fragment thereof comprising 15 or more consecutive nucleotides; (i) a polynucleotide comprising a nucleotide sequence complementary to a nucleotide sequence represented by any of SEQ ID NOs: 1 to 10, 12 to 70, and 72 to 275 or a nucleotide sequence derived from the nucleotide sequence by the replacement of u with t; and (j) a polynucleotide hybridizing under stringent conditions to any of the polynucleotides (f) to (i).
- The method according to any one of claims 8 to 13, wherein the subject is a human.
- Use of an ovarian tumor marker polynucleotide of miR-1233-5p as a target nucleic acid in an in vitro method of detecting an ovarian tumor in a blood, serum, or plasma sample obtained from a subject.
- The use according to claim 15, wherein miR-1233-5p is used together with one or more polynucleotides selected from the group consisting of other ovarian tumor markers: miR-4675, miR-4783-3p, miR-1228-5p, miR-4532, miR-6802-5p, miR-6784-5p, miR-3940-5p, miR-1307-3p, miR-8073, miR-3184-5p, miR-6088, miR-5195-3p, miR-320b, miR-4649-5p, miR-6800-5p, miR-1343-3p, miR-4730, miR-6885-5p, miR-5100, miR-1203, miR-6756-5p, miR-373-5p, miR-1268a, miR-1260b, miR-4258, miR-4697-5p, miR-1469, miR-4515, miR-6861-5p, miR-6821-5p, miR-575, miR-6805-5p, miR-4758-5p, miR-3663-3p, miR-4530, miR-6798-5p, miR-6781-5p, miR-885-3p, miR-1273g-3p, miR-4787-3p, miR-4454, miR-4706, miR-1249-3p, miR-887-3p, miR-6786-5p, miR-1238-5p, miR-6749-5p, miR-6729-5p, miR-6825-5p, miR-663b, miR-6858-5p, miR-4690-5p, miR-6765-5p, miR-4710, miR-6775-5p, miR-371a-5p, miR-6816-5p, miR-296-3p, miR-7977, miR-8069, miR-6515-3p, miR-4687-5p, miR-1343-5p, miR-7110-5p, miR-4525, miR-3158-5p, miR-6787-5p, miR-614, miR-4689, miR-1268b, miR-1228-3p, miR-1185-1-3p, miR-940, miR-939-5p, miR-6757-5p, miR-1275, miR-5001-5p, miR-6826-5p, miR-6765-3p, miR-3679-3p, miR-4718, miR-4286, miR-8059, miR-4447, miR-4448, miR-658, miR-6766-3p, miR-197-5p, miR-6887-5p, miR-6742-5p, miR-6729-3p, miR-5090, miR-7975, miR-4505, miR-6889-5p, miR-4708-3p, miR-6131, miR-1225-3p, miR-6132, miR-4734, miR-3194-3p, miR-638, miR-2467-3p, miR-4728-5p, miR-5572, miR-6789-5p, miR-8063, miR-4429, miR-6840-3p, miR-4476, miR-675-5p, miR-711, miR-6875-5p, miR-3160-5p, miR-1908-5p, miR-6726-5p, miR-1913, miR-8071, miR-3648, miR-4732-5p, miR-4787-5p, miR-3917, miR-619-5p, miR-1231, miR-342-5p, miR-4433a-5p, miR-6766-5p, miR-4707-5p, miR-7114-5p, miR-6872-3p, miR-6780b-5p, miR-7845-5p, miR-6798-3p, miR-665, miR-6848-5p, miR-5008-5p, miR-4294, miR-6511a-5p, miR-4435, miR-4747-3p, miR-6880-3p, miR-6869-5p, miR-7150, miR-1260a, miR-6877-5p, miR-6721-5p, miR-4656, miR-1229-5p, miR-4433a-3p, miR-4274, miR-4419b, miR-4674, miR-6893-5p, miR-6763-3p, miR-6762-5p, miR-6738-5p, miR-4513, miR-6746-5p, miR-6880-5p, miR-4736, miR-718, miR-6717-5p, miR-7847-3p, miR-760, miR-1199-5p, miR-6813-5p, miR-6769a-5p, miR-1193, miR-7108-3p, miR-6741-5p, miR-4298, miR-6796-3p, miR-4750-5p, miR-6785-5p, miR-1292-3p, miR-4749-3p, miR-6800-3p, miR-4722-5p, miR-4746-3p, miR-4450, miR-6795-5p, miR-365a-5p, miR-498, miR-6797-5p, miR-1470, miR-6851-5p, miR-1247-3p, miR-5196-5p, miR-208a-5p, miR-6842-5p, miR-150-3p, miR-4534, miR-3135b, miR-3131, miR-4792, miR-6510-5p, miR-504-3p, miR-3619-3p, miR-671-5p, miR-4667-5p, miR-4430, miR-3195, miR-3679-5p, miR-6076, miR-6515-5p, miR-6820-5p, miR-4634, miR-187-5p, miR-6763-5p, miR-1908-3p, miR-1181, miR-6782-5p, miR-5010-5p, miR-6870-5p, miR-6124, miR-1249-5p, miR-6511b-5p, miR-1254, miR-4727-3p, miR-4259, miR-4771, miR-3622a-5p, miR-4480, miR-4740-5p, miR-6777-5p, miR-6794-5p, miR-4687-3p, miR-6743-5p, miR-6771-5p, miR-3141, miR-3162-5p, miR-4271, miR-1227-5p, miR-4257, miR-4270, miR-4516, miR-4651, miR-4725-3p, miR-6125, miR-6732-5p, miR-6791-5p, miR-6819-5p, miR-6891-5p, miR-7108-5p, miR-7109-5p, miR-642b-3p, and miR-642a-3p, and/or miR-320a, miR-663a, miR-328-5p, miR-128-2-5p, miR-125a-3p, miR-191-5p, miR-92b-5p, miR-296-5p, miR-1246, miR-92a-2-5p, miR-128-1-5p, miR-1290, miR-211-3p, miR-744-5p, miR-135a-3p, miR-451a, miR-625-3p, miR-92a-3p, miR-422a, miR-483-5p, miR-652-5p, miR-24-3p, miR-23b-3p, miR-23a-3p, miR-92b-3p, and miR-22-3p.
Description
TECHNICAL FIELD The present invention relates to a kit or a device for detection of ovarian tumor, comprising a nucleic acid capable of specifically binding to a particular miRNA or a complementary strand thereof, which is used for examining the presence or absence of ovarian tumor in a subject, and a method for detecting ovarian tumor, comprising measuring an expression level of the miRNA using the nucleic acid. BACKGROUND ART The ovary is the female reproductive organ that produces an ovum and one each is found on both sides of the uterus. Fallopian tube is a tube through which an ovum, when released from the ovary, travels down into the uterus in which the fertilized ovum is implanted and grows into the fetus. The ovary further functions to secrete female hormones such as estrogen and progesterone. The ovary is considered an organ prone to develop tumors, which are roughly classified into surface epithelial-stromal tumors, sex cord-stromal tumor, and germ cell tumor based on the origin of tumorigenesis. The ovarian tumors are categorized into benign, borderline malignant, and malignant, and borderline malignant and malignant ovarian tumors are called ovarian cancers. Ovarian cancer incidence rate of 2012 in Japan disclosed by the Center for Cancer Control and Information Services, National Cancer Center was 9,384 people, in other words, 1 out of every 87 Japanese women had the cancer, causing the number of ovarian cancer deaths to climb to 4,840 people in 2014. In the United States, it is said that one in every 75 women develops ovarian cancer and the estimated number of people affected by ovarian cancer in 2017 climbed to 22,440 people, out of which about 14,080 people are expected to die. A stage of progression of ovarian cancer and fallopian tube cancer is defined according to a tumor being unilateral or bilateral, the presence or absence of peritoneal dissemination, lymph node metastasis and distant metastasis, the size, and the like, and is classified into stages IA, IB, IC (IC1, IC2, IC3), IIA, IIB, IIIA1, IIIA2, IIIB, IIIC, IVA, and IVB. Five-year relative survival rate in ovarian cancer depends largely on a stage of progression of the cancer, and it is reported that the rate is 92% in the case of a localized cancer, 73% in the case of a peripheral region cancer, and 29% in the case of a distant metastatic cancer. Thus, early detection of ovarian cancer leads to improvement in survival rate and the provision of means for enabling the early detection is strongly required. Treatment of ovarian cancer is surgical therapy in principal but drug therapy is concurrently used depending on a stage of progression, metastasis, systemic conditions, and the classification of ovarian cancer. Particularly, in the case that an ovarian cancer is detected early as stage I, a removal operation of an ovary or fallopian tube only on the side at which the cancer is detected may be sufficient instead of the total removal of the uterus, ovaries or fallopian tubes, whereby women can save a chance for future childbirth. Early ovarian cancer and benign ovarian tumor are often asymptomatic, and even progressive ovarian cancer often only involves general symptoms which could be caused by other reasons such as abdominal bloating sensation and pains, because of which it is difficult to detect ovarian tumor based on subjective symptoms. Extensive studies on the screening test for ovarian cancer have been conducted but no substantial achievement is accomplished, and only two methods are actually usable: transvaginal ultrasound test and a CA-125 blood marker test. The secondary test for ovarian cancer includes imaging tests such as ultrasonography, CT scanning test, MRI, and PET/CT test. As shown in Patent Literatures 1 to 4 and Non-Patent Literatures 1 to 3, there are reports, albeit at a research stage, on the detection of ovarian tumor using the expression levels of microRNAs (miRNAs) in biological samples including blood. Specifically, Patent Literature 1 discloses a method for detecting ovarian cancer or predicting prognosis using miR-191, miR-24, miR-320, miR-328, miR-625-3p, miR-483-5p, miR-92a, miR-1290 and the like in plasma. Patent Literature 2 discloses miR-135a-3 and the like in blood as biomarkers for gynecologic cancers. Patent Literature 3 discloses miR-125a-3p, miR-211-3 and the like as biomarkers for ovarian cancers using human sample tissues. Patent Literature 4 discloses a method for discriminating endometriosis-derived ovarian cancer and serous ovarian cancer from endometriosis using miR-191-5p, miR-652-5p, miR-744-5p, miR-1246 and the like in plasma. Non-Patent Literature 1 discloses miR-92a, miR-128, miR-191-5p, miR-296-5p, miR-320a, miR-625-3p and the like in blood as circulating extracellular miRNAs involved in ovarian cancer. Non-Patent Literature 2 discloses that there are differences in expression levels of miR-22, miR-45 and the like as a result of analyzing miRNAs from serum samples of ovarian cancer p