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Construction of cfDNA quality management and quality check system in genetic testing

Research Project

Project/Area Number 18K07451
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 52010:General internal medicine-related
Research InstitutionSaga University

Principal Investigator

Sato Akemi  佐賀大学, 医学部, 助教 (20568357)

Co-Investigator(Kenkyū-buntansha) 末岡 榮三朗  佐賀大学, 医学部, 教授 (00270603)
中村 秀明  佐賀大学, 医学部, 助教 (10452616)
Project Period (FY) 2018-04-01 – 2021-03-31
Project Status Completed (Fiscal Year 2020)
Budget Amount *help
¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000)
Fiscal Year 2020: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2019: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2018: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
KeywordsLiquid biopsy / cfDNA / 品質管理 / 遺伝子検査 / NGS / 品質 / 保存
Outline of Final Research Achievements

Liquid biopsy with circulating free DNA (cfDNA) is a recommended alternative method of re-biopsy. Quality control with cfDNA is indispensable for precise examinations, and it is desirable to achieve high-quality cfDNA separation. We investigated two issues: the influence of pre-analytical procedures on cfDNA analysis performed as a routine procedure in a standard clinical laboratory, and the extent of deterioration of cfDNA quality due to long-term storage. Comparisons among blood collection tube types, storage temperatures, and periods of blood separation were performed in terms of cfDNA quantification, cfDNA size distribution, and detection of EGFR mutations. Quality of cfDNA was better with collection tubes containing 3.2% sodium citrate than with those containing EDTA 2K, and was maintained with storage at 4℃ for up to 72 h after blood collection, equivalent to results with cell-stabilizing blood collection tubes.

Academic Significance and Societal Importance of the Research Achievements

Liquid biopsy検体については国内外多くの研究があり、それは主に検査系の開発やその機能解析である。検体そのものについては4~5年前から少しずつ論文となっているが、現在cfDNAについては血清ではなく血漿から抽出されているのが現状である。今回の研究成果では。cfDNA分析に対する分析前の手順の影響については抗凝固剤の種類、保存温度、および血液分離の期間の間の比較は、cfDNAの定量化、cfDNAのサイズ分布、およびEGFR変異の検出の観点から解析を行い、Liquid biopsyの標準化された分析前手順の確立に近づいていると考えている。

Report

(4 results)
  • 2020 Annual Research Report   Final Research Report ( PDF )
  • 2019 Research-status Report
  • 2018 Research-status Report
  • Research Products

    (3 results)

All 2018

All Journal Article (1 results) (of which Peer Reviewed: 1 results,  Open Access: 1 results) Presentation (2 results)

  • [Journal Article] Investigation of appropriate pre-analytical procedure for circulating free DNA from liquid biopsy2018

    • Author(s)
      3.Sato A, Nakashima C, Abe T, Kato J, Hirai M, Nakamura T, Komiya K, Kimura S, Sueoka E, Sueoka-Aragane N
    • Journal Title

      Oncotarget

      Volume: 9 Issue: 61 Pages: 31904-31914

    • DOI

      10.18632/oncotarget.25881

    • Related Report
      2018 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] Liquid biopsyのためのプレアナリシス段階の検体品質管理に関する検討2018

    • Author(s)
      佐藤 明美、中島 千穂、安部 友範、中村 秀明、荒金 尚子、木村 晋也、末岡榮三朗
    • Organizer
      第58回日本臨床化学会年時学術集会
    • Related Report
      2018 Research-status Report
  • [Presentation] 遺伝子検査におけるcirculating free DNAの保存条件に関する検討2018

    • Author(s)
      佐藤 明美、中島 千穂、安部 友範、中村 秀明、荒金 尚子、木村 晋也、末岡榮三朗
    • Organizer
      日本臨床検査自動化学会 第50回大会
    • Related Report
      2018 Research-status Report

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Published: 2018-04-23   Modified: 2022-01-27  

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