Establishment of a Novel Screening Test for Diagnosing Hepatocellular Carcinoma based on a Sensitive DNA Methylation Assay
Project/Area Number |
20K08332
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Research Category |
Grant-in-Aid for Scientific Research (C)
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Allocation Type | Multi-year Fund |
Section | 一般 |
Review Section |
Basic Section 53010:Gastroenterology-related
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Research Institution | Yamaguchi University |
Principal Investigator |
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Co-Investigator(Kenkyū-buntansha) |
末廣 寛 山口大学, 大学院医学系研究科, 准教授 (40290978)
高見 太郎 山口大学, 大学院医学系研究科, 教授 (60511251)
佐伯 一成 山口大学, 医学部附属病院, 講師 (60634756)
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Project Period (FY) |
2020-04-01 – 2023-03-31
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Project Status |
Completed (Fiscal Year 2022)
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Budget Amount *help |
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2022: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2021: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2020: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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Keywords | 肝細胞癌 / リキッドバイオプシー / メチル化 / SEPT9 / 肝癌 / 診断 |
Outline of Research at the Start |
肝細胞癌(以下肝癌)の診断に有効なスクリーニングシステムとして、「簡便で侵襲が少なく精度の高いスクリーニング検査」の開発が喫緊の課題である。その解決策として、リキッドバイオプシー検査があり、我々は新たにSEPT9メチル化高感度解析法によるリキッドバイオプシーを開発した。今回、そのバリデーションスタディおよび肝癌のリスクを有する糖尿病患者における肝癌診断スクリーニングシステムを構築し、その有用性を検証する。
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Outline of Final Research Achievements |
In recent years, patients with hepatitis virus related hepatocellular carcinoma (HCC) are decreasing in Japan. The patients with non-viral HCC are often diagnosed at an advanced stage. Against this background, the establishment of a novel HCC surveillance system for early HCC detection is required regardless of the etiology of HCC. To solve this problem, we have developed a novel liquid biopsy test based on a sensitive methylated SEPT9 (m-SEPT9) assay. We achieved a test sensitivity of 63.2% for overall HCC and 42% for early HCC. We enrolled 151 HCC patients in the validation study to evaluate its usefulness. The overall positive rate of HCC was 63.6%, and the positive rates for viral and non-viral HCC were 63.3% and 63.9%, respectively, with no significant difference. The positive rate in early HCC (BCLC-stage 0/A) was 45.1%. Therefore, the results in the validation cohort were similar to those in the training cohort, so we could validate the usefulness of our sensitive m-SEPT9 assay.
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Academic Significance and Societal Importance of the Research Achievements |
肝癌は、他の消化器癌に比べ、難治かつ予後不良である。近年は、非ウイルス性肝癌が増加し、進行肝癌で発見されることも多く、早期発見は予後改善の一番の近道であるが、特に非ウイルス性肝癌に対する肝癌サーベイランスによる早期診断の構築はない。本研究成果は、ウイルス性ならびに非ウイルス性肝癌に関係なく、高感度メチル化解析法によるm-SEPT9測定の有用性が証明できたことから意義のある成果である。社会的意義としては、早期肝癌の5年生存率は約70%に対して、ステージIVの進行肝癌では約20%と著明に低下することから、早期発見により、肝癌の死亡者数減少につながり、健康寿命の延伸を実現できる。
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Report
(4 results)
Research Products
(59 results)
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[Journal Article] Impact of skeletal muscle volume on patients with BCLC stage-B hepatocellular carcinoma undergoing sorafenib therapy2023
Author(s)
Saeki I, Yamasaki T, Yamauchi Y, Kawaoka T, Uchikawa S, Hiramatsu A, Aikata H, Kobayashi K, Kondo T, Ogasawara S, Chiba T, Kawano R, Chayama K, Kato N, Takami T.
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Journal Title
Cancer Med.
Volume: -
Issue: 9
Pages: 10625-10635
DOI
Related Report
Peer Reviewed / Open Access
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[Journal Article] Management of Systemic Therapies and Hepatic Arterial Infusion Chemotherapy in Patients with Advanced Hepatocellular Carcinoma Based on Sarcopenia Assessment2022
Author(s)
Yamasaki T, Saeki I, Yamauchi Y, Matsumoto T, Suehiro Y, Kawaoka T, Uchikawa S, Hiramatsu A, Aikata H, Kobayashi K, Kondo T, Ogasawara S, Chiba T, Takami T, Chayama K, Kato N, Sakaida I.
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Journal Title
Liver Cancer.
Volume: 11
Issue: 4
Pages: 329-340
DOI
Related Report
Peer Reviewed / Open Access
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[Journal Article] Final Results of TACTICS: A Randomized, Prospective Trial Comparing Transarterial Chemoembolization Plus Sorafenib to Transarterial Chemoembolization Alone in Patients with Unresectable Hepatocellular Carcinoma2022
Author(s)
Kudo M, Ueshima K, Ikeda M, Torimura T, Tanabe N, Aikata H, Izumi N, Yamasaki T, Nojiri S, Hino K, Tsumura H, Kuzuya T, Isoda N, Moriguchi M, Aino H, Ido A, Kawabe N, Nakao K, Wada Y, Ogasawara S, Yoshimura K, Okusaka T, Furuse J, Kokudo N, Okita K, Johnson PJ, Arai Y.
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Journal Title
Liver Cancer.
Volume: 11
Issue: 4
Pages: 354-367
DOI
Related Report
Peer Reviewed / Open Access / Int'l Joint Research
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[Journal Article] 臨床検査技師を含む多職種連携による院内肝炎ウイルス検査陽性者受診勧奨の取り組み2021
Author(s)
日高勲 , 大野高嗣 , 藤永亜季 , 増井美由紀 , 久永拓郎 , 佐伯一成 , 松本俊彦 , 丸本芳雄 , 石川剛 , 高見太郎 , 川野伶緒 , 山﨑隆弘 , 坂井田功
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Journal Title
肝臓
Volume: 62
Pages: 448-455
NAID
Related Report
Peer Reviewed / Open Access
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[Journal Article] Clinical Benefits of Hepatic Arterial Infusion Chemotherapy for Advanced Hepatocellular Carcinoma.2021
Author(s)
Yamasaki T, Saeki I, Kotoh-Yamauchi Y, Sasaki R, Tanabe N, OonoT, Matsuda T, Takuro Hisanaga T, Matsumoto T, Hidaka I, Ishikawa T, Takami T, Suehiro Y, Sakaida I.
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Journal Title
Applied Sciences(Basel)
Volume: 11
Pages: 1882-1882
Related Report
Peer Reviewed / Open Access
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[Journal Article] Fecal DNA Testing of TWIST1 Methylation Identifies Patients With Advanced Colorectal Adenoma Missed by Fecal Immunochemical Test for Hemoglobin2020
Author(s)
Suehiro Y, Hashimoto S, Goto A, Yamaoka Y, Yamamoto N, Suzuki N, Higaki S, Fujii I, Suzuki C, Matsumoto T, Hoshida T, Koga M, Tsutsumi T, Lim LA, Matsubara Y, Takami T, Yoshida S, Hazama S, Yotsuyanagi H, Nagano H, Sakaida I, Yamasaki T.
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Journal Title
Clinical and Translational Gastroenterology
Volume: 11
Issue: 6
Pages: e00176-e00176
DOI
Related Report
Peer Reviewed / Open Access
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[Journal Article] Microbicidal effect of deep ultraviolet light-emitting diode irradiation2020
Author(s)
Takagi Tatsuya、Nishikawa Jun、Yanagihara Masashi、Fukuda Soichiro、Kubota Naoto、Kobayashi Yuki、Otsuyama Ken-ichiro、Nojima Junzo、Tsuneoka Hidehiro、Sakai Kohei、Suehiro Yutaka、Yamasaki Takahiro、Sakurai Kenji、Itatani Kazuki、Sakaida Isao
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Journal Title
Lasers in Medical Science
Volume: -
Issue: 4
Pages: 00-00
DOI
Related Report
Peer Reviewed / Open Access / Int'l Joint Research
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[Journal Article] Effect of Handgrip Strength on Clinical Outcomes of Patients with Hepatocellular Carcinoma Treated with Lenvatinib.2020
Author(s)
Kotoh Y, Saeki I, Yamasaki T, Sasaki R, Tanabe N, Oono T, Matsuda T, Hisanaga T, Matsumoto T, Hidaka I, Ishikawa T, Takami T, Sakaida I.
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Journal Title
Applied Sciences(Basel)
Volume: 10
Pages: 5403-5403
Related Report
Peer Reviewed / Open Access
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[Presentation] Impact of skeletal muscle volume in patients with intermediate-stage hepatocellular carcinoma (HCC) receiving sorafenib: A comparison with advanced HCC patients2021
Author(s)
Issei Saeki , Takahiro Yamasaki, Yurika Yamauchi, Tomokazu Kawaoka, Shinsuke Uchikawa, Akira Hiramatsu, Hiroshi Aikata, Kazufumi Kobayashi, Takayuki Kondo 4, Sadahisa Ogasawara, Tetsuhiro Chiba, Kazuaki Chayama, Naoya Kato, Isao Sakaida, Taro Takami
Organizer
APASL Oncology 2021
Related Report
Int'l Joint Research
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[Presentation] 超高感度血清中メチル化DNA解析による胃癌スクリーニングの試み2020
Author(s)
秀浦栄三郎, 岡本健志, 五嶋敦史, 橋本真一, 星田朋美, 藤郁英, 鈴木 千衣子, 檜垣真吾, 末廣 寛, 西川 潤, 山﨑隆弘, 坂井田 功
Organizer
第106回日本消化器病学会総会
Related Report
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