| Project/Area Number |
20K17614
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| Research Category |
Grant-in-Aid for Early-Career Scientists
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| Allocation Type | Multi-year Fund |
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| Review Section |
Basic Section 55020:Digestive surgery-related
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| Research Institution | Osaka University |
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Principal Investigator |
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| Project Period (FY) |
2020-04-01 – 2022-03-31
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| Project Status |
Completed (Fiscal Year 2021)
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| Budget Amount *help |
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2021: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2020: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
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| Keywords | ctDNA / GIST / cell free DNA / circulating tumor DNA |
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| Outline of Research at the Start |
消化管間質腫瘍(GIST)は原因遺伝子変異が同定されている疾患(c-kit遺伝子やPDGFRA遺伝子の突然変異)であり、さらに治療耐性獲得時には特定の部位に二次遺伝子変異が起こることが明らかにされている。今回、当院にて治療中のGIST患者を対象とし血漿中ctDNAにおける2次遺伝子変異をモニタリングし、治療耐性獲得の早期診断法として確立することを目的とする。最終的には、承認申請用臨床データを取得、企業との共同研究契約のもと、企業連携のうえ体外診断キットとして製造販売、薬事承認申請することを目標としたい。
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| Outline of Final Research Achievements |
Last year, we conducted a feasibility study of real-time PCR using the PVA sponge method. We examined the condition setting of real-time PCR using the PVA sponge method, and developed a more stable and quantitative column method. In addition, we developed a direct method for efficient measurement of a large number of samples in a real clinical setting.
In this year, we further demonstrated the superiority of the PVA sponge method (column method) over existing cfDNA assay kits using blood samples from healthy subjects, GIST patients, and cancer patients, and also demonstrated that the PVA sponge method is more efficient in collecting cfDNA than the existing cfDNA assay kits, and that the PVA sponge method can be used with several sizes of cfDNA samples regardless of the size of the samples. The method was shown to be capable of recovering and measuring cfDNA.
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| Academic Significance and Societal Importance of the Research Achievements |
本研究開発により、簡便な方法で血液中のcfDNAやctDNAが回収、測定、解析可能となれば、今回対象としたGISTのみならず他の癌腫を対象とした癌の存在診断や再発診断に有用である可能性が高く、多くの国民やがん患者にとってその学術的意義や社会的意義が高いと考えられる。
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