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Ep 3106873 A1 (19) TZZ¥_Z¥_T (11) EP 3 106 873 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 21.12.2016 Bulletin 2016/51 G01N 33/574 (2006.01) C12Q 1/68 (2006.01) G01N 33/53 (2006.01) C12N 15/09 (2006.01) (21) Application number: 16181416.5 (22) Date of filing: 23.10.2008 (84) Designated Contracting States: (72) Inventors: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR • Okano, Fumiyoshi HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT Kamakura-shi, Kanagawa 248-8555 (JP) RO SE SI SK TR • Suzuki, Kana Kamakura-shi, Kanagawa 248-8555 (JP) (30) Priority: 25.10.2007 JP 2007277697 25.10.2007 JP 2007277747 (74) Representative: Denison, Christopher Marcus et al 26.10.2007 JP 2007279512 Mewburn Ellis LLP 26.10.2007 JP 2007279580 City Tower 30.09.2008 JP 2008254170 40 Basinghall Street London EC2V 5DE (GB) (62) Document number(s) of the earlier application(s) in accordance with Art. 76 EPC: Remarks: 08842391.8 / 2 207 037 This application was filed on 27-07-2016 as a divisional application to the application mentioned (71) Applicant: Toray Industries, Inc. under INID code 62. Tokyo 103-8666 (JP) (54) METHOD FOR DETECTION OF CANCER (57) A method for detecting a cancer(s) based on an cer-bearing living body. Because these polypeptides re- expression of prescribed polypeptides is disclosed. act with antibodies specifically existing in serum of a can- Thesepolypeptides were isolated, by the SEREX method cer patient, cancers in a living body can be detected by using a cDNA library derived from canine testis and se- measuring the antibody in a sample. Cancers in a living rum from a cancer-bearing dog, as a polypeptide which body can also be detected by measuring the antigen pro- binds to an antibody existing in serum derived from can- tein of the antibody per se or mRNA encoding it. EP 3 106 873 A1 Printed by Jouve, 75001 PARIS (FR) EP 3 106 873 A1 Description TECHNICAL FIELD 5 [0001] The present invention relates to a novel method for detecting a cancer(s). BACKGROUND ART [0002] Cancers are the commonest cause for death among all of the causes for death, and the main therapies therefor 10 are palliative treatment in which surgical treatment is combined with radiotherapy and chemotherapy. By virtue of the advance in medical technology, cancers have become such diseases that can be highly possibly cured if they can be found in the early stage. Therefore, a detection method of cancer which can be easily carried out by testing serum, urine or the like without physical and economical burden to patients is demanded. [0003] Recently, methods wherein tumor products such as tumor markers are measured have been widely used as 15 diagnostic methods using blood or urine. Examples of the tumor product include tumor-related antigens, enzymes, specific proteins, metabolites, tumor genes, products of tumor genes, and tumor-suppressor genes. In some cancers, a carcinoembryonic antigen CEA, glycoproteins CA19-9 and CA125, a prostate-specific antigen PSA, calcitonin which is a peptide hormone produced in thyroid and the like are utilized as tumor markers in cancer diagnosis. However, in most types of cancers, there are no tumor markers useful for cancer diagnosis. Further, since most of the tumor markers 20 currently known exist only in very small amounts (e.g., in the order of pg/mL) in body fluid, their detection requires a highly sensitive measurement method or a special technique. Under such circumstances, if a novel cancer test method by which various cancers can be detected by simple operations is provided, its use for diagnosis of various cancers are expected to be developed. [0004] The method would be very useful if it further enables diagnosis of cancers developed in invisible parts, assess- 25 ment of the stage of cancer progression, assessment of the grade of cancer malignancy, follow-up of postoperative patients, diagnosis of recurrence, diagnosis of metastasis, monitoring of therapy and the like, in addition to detection of cancers. [0005] More particularly, if a method which enables diagnosis of cancers developed in invisible parts is provided, it would be useful for early detection of cancers in parts where cancers are hardly realized, for example, the inside of the 30 abdominal cavity. Further, even in cases where the tumor is too small to be found visually, detection of such cancers that cannot be found by ultrasonography, CT (computed tomography) or MRI (magnetic resonance imaging) is also made possible. [0006] The stage of cancer progression is classified based on the extent of expansion of the tumor at the primary site and whether or not metastasis has occurred to a regional lymph node or a distant organ. In general, the disease stage 35 is classified into 5 stages, wherein a larger number indicates a more advanced state. Although, strictly speaking, the definition varies depending on organs, the disease stage 0 indicates a cancer staying within epithelium and the stage IV indicates a cancer with distant metastasis. If the stage of cancer progression as described above can be determined, determination of an appropriate therapeutic strategy and, in addition, assessment of therapeutic effects of anticancer drugs are made possible. In regard to the determination of the therapeutic strategy, for example, some of prostate 40 cancers are low malignant and hardly progress, hence do not require treatment; and others are progressive and metas- tasize to bones and/or the like, causing pain and death of patients. Since hormonotherapy and extirpative surgery are accompanied by side effects, it is necessary to appropriately judge and determine the therapeutic approach. Further, if whether the selected anticancer drug is appropriate or not, when to end the administration of the anticancer drug and the like can be appropriately judged, the physical and economical burden on the patient can also be reduced. Therefore, 45 it is important that the stage of progression can be assessed. [0007] One of the characteristics of cancer cells is blastogenesis, that is, dedifferentiation. Except for a part of cancers, lower-differentiated cancer cells such as those poorly differentiated or undifferentiated grow more rapidly after the me- tastasis, and the prognosis is poor. Such cancers are said to be highly malignant. Conversely, highly-differentiated cancer cells, that is, those showing a high degree of cell differentiation maintain the structural and functional traits of the 50 organ from which they were originated, and can be said to be less malignant. If such cancer malignancy can be determined, it is made possible to secure a larger margin of excision of the tumor in cases where its malignancy is high even if the size of the tumor is small, as well as to follow up the patient, paying attention to larger areas in the surrounding tissues. [0008] In cases where diagnosis of the postoperative course including recurrence and metastasis is possible, diagnosis of whether the tumor has been completely excised by the operation is made possible. Since recurrence is likely to occur 55 in cases where the excision was incomplete, this can be used as a basis for judging whether a more careful follow up of the patient at short intervals is necessary and, in some cases, for deciding whether an early reoperation should be carried out. Furthermore, recurrent cancer can be found at its early stage with a high possibility. In the case of distant metastasis, its detection is likely to be late, but if a method which enables diagnosis of metastasis is provided, a basis 2 EP 3 106 873 A1 for deciding whether the region to be checked should be extended in addition to the site where the tumor was excised and the vicinity thereof can be obtained. [0009] If monitoring of therapy is possible, an appropriate therapeutic method or combination of therapeutic methods can be selected among various therapeutic methods to optimize the therapy. If one can see the therapeutic effects of 5 anticancer agents, selection of the dosing periods and the types and doses of anticancer agents may be made easier. Further, after excision of the tumor, one can know presence/absence of remaining tumor, and during follow up of the patient, one can have a clue to find metastasis or recurrence as early as possible, so that initiation of early treatment is possible. If monitoring of a therapeutic effect is possible, whether the therapeutic approach was appropriate and whether the therapeutic approach should be changed to another can be judged. 10 [0010] It is known that dogs age 7 times faster than human. Recently, a companion animal is kept as a member of a family and often has a lifestyle similar to that of its owner. Therefore, if the companion animal is suffering from cancer, it is possible to predict that the owner has a high risk of development of cancer in the future. If accurate diagnosis of cancer in companion animals is possible, it is expected to be useful as a clue for prophylaxis of cancer in the owners. [0011] It is said that about 6,390,000 and about 17,640,000 dogs are currently kept in Japan and the U.S., respectively. 15 Since, in addition to rabies vaccination, combination vaccines such as pentavalent, heptavalent and octavalent vaccines have become popular, occurrence of highly lethal infectious diseases such as canine parvovirus infection, canine dis- temper virus infection, canine parainfluenza (kennel cough), canine adenovirus type II infection (kennel cough), canine infectious hepatitis, canine coronavirus infection and leptospirosis decreased. Therefore, the average life expectancy of dogs increased, and aged dogs of 7 years old or older occupy 35.5% of the total number of the kept dogs.
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