| Project/Area Number |
17K07202
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Tumor diagnostics
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| Research Institution | Kitasato University |
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Principal Investigator |
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Project Status |
Completed (Fiscal Year 2019)
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| Budget Amount *help |
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2019: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2018: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2017: ¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
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| Keywords | 肺癌 / バイオマーカー / リキッドバイオプシー / 生検 / プレシジョンメディスン / 分子標的 / EGFR / T790M |
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| Outline of Final Research Achievements |
EGFR mutations is very important for decision making to treat lung cancer. We prospectively evaluated the detection methods of EGFR mutations in tissue re-biopsy and liquid biopsy (plasma and serum) using high sensitivity method (PNA-LNA PCR clamp, mainly done in JAPAN) and new PCR-based method (COBAS ver2, mainly done in USA and EU).
Detection of EGFR mutation by COBAS ver2 and by PNA-LNA method was almost the same in tissue. The detection rate of T790M was lower than that of the original EGFR mutation in liquid biopsy compared to that in tissue re-biopsy. The detection of T790M in serum exhibited a higher specificity and positive predictive value than that in plasma.The detection sensitivity of T790M was similar in plasma and serum. Plasma, serum, and tissue genotyping can have complementary roles for detecting EGFR-T790M. Repeated tests with different samples and different methods may improve accuracy of EGFR mutation detection and will lead to the maximum benefit for the patient.
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| Academic Significance and Societal Importance of the Research Achievements |
肺癌のバイオマーカーとしてのEGFR遺伝子変異に関して、治療方針決定のための感受性変異および耐性変異検出方法を前向き研究により検討した。血液を用いたリキッドバイオプシーの有用性と限界、血漿と血清での差を詳細に検討し、EGFR阻害剤耐性肺癌患者での変異検出方法に関して本邦でも広く行われるようになったCobas法に関して基礎的な情報を与えるものとなった。英文論文（Onco Targets Ther 2018)、学会発表（2019年世界肺癌学会、2018年日本肺癌学会、他)により公表した。さらに、基礎的なEGFR阻害剤耐性肺癌細胞株での耐性機序に関して検討し発表した（2019年日本肺癌学会）。
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