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Design and analysis of clinical studies for personalized medicine

Research Project

Project/Area Number 20590599
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Hygiene
Research InstitutionThe Institute of Statistical Mathematics

Principal Investigator

MATSUI Shigeyuki  The Institute of Statistical Mathematics, データ科学研究系, 教授 (80305854)

Co-Investigator(Kenkyū-buntansha) MORITA Satoshi  横浜市立大学, 医学研究科, 教授 (60362480)
山中 竹春  国立病院機構九州がんセンター, 臨床研究部, 研究員 (00325466)
大門 貴志  兵庫医科大学, 医学部, 講師 (40372156)
Co-Investigator(Renkei-kenkyūsha) YAMANAKA Takeharu  九州がんセンター, 臨床研究部, 室長 (00325466)
DAIMON Takashi  兵庫医科大学, 医学部, 講師 (40372156)
Project Period (FY) 2008 – 2010
Project Status Completed (Fiscal Year 2010)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2010: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2009: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2008: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywords医学統計 / ゲノム薬理学 / 個別化医療 / ゲノムワイド研究 / 分子診断法の開発 / マイクロアレー / 臨床研究の計画と解析 / 階層混合モデル / 遺伝子スクリーニング / 体外診断法の開発 / ベイズ流階層混合モデル
Research Abstract

Development of molecular diagnostics is essential for establishing personalized medicine based on genetic characteristics of individual patients. In this research, we studied design and analysis of clinical studies for developing molecular diagnostics. In particular, we developed statistical methods for identifying molecular markers associated with clinical variables such as disease type, response to treatment, and survival outcomes, from a large pool of candidate molecular markers, making prediction systems using the identified molecular markers, and testing their clinical utility.

Report

(4 results)
  • 2010 Annual Research Report   Final Research Report ( PDF )
  • 2009 Annual Research Report
  • 2008 Annual Research Report
  • Research Products

    (42 results)

All 2011 2010 2009 2008 Other

All Journal Article (29 results) (of which Peer Reviewed: 28 results) Presentation (12 results) Remarks (1 results)

  • [Journal Article] Estimation and selection in high-dimensional genomic studies for developing molecular diagnostics.2011

    • Author(s)
      Matsui S, Noma H
    • Journal Title

      Biostatistics 12巻

      Pages: 223-233

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Estimation and selection in high-dimensional genomic studies for developing molecular diagnostics.2011

    • Author(s)
      Matsui S, Noma H
    • Journal Title

      Biostatistics

      Volume: 12 Pages: 223-233

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Optimality of gene ranking based on univariate P-values for detecting differentially expressed genes.2010

    • Author(s)
      Noma H, Matsui S
    • Journal Title

      Japanese Journal of Biometrics. 31巻

      Pages: 13-21

    • NAID

      10026601622

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Evaluating the impact of prior assumptions in Bayesian biostatistics.2010

    • Author(s)
      Morita S, Thall PF, Muller P
    • Journal Title

      Statistics in Biosciences 2巻

      Pages: 1-17

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Optimality of gene ranking based on univariate P-values for detecting differentially expressed genes.2010

    • Author(s)
      Noma H, Matsui S.
    • Journal Title

      Japanese Journal of Biometrics

      Volume: 31 Pages: 13-21

    • NAID

      10026601622

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Evaluating the impact of prior assumptions in Bayesian biostatistics.2010

    • Author(s)
      Morita S, Thall PF, Muller P
    • Journal Title

      Stat Biosci.

      Volume: 2 Pages: 1-17

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A human epidermal growth factor receptor 2 expression-based approach to neoadjuvant chemotherapy for operable breast cancer.2010

    • Author(s)
      Ishikawa T, Shimizu D, Sasaki T, Morita S, Tanabe M, Ota I, Kawachi K, Nozawa A, Chishima T, Ichikawa Y, Endo I, Shimada H
    • Journal Title

      Jpn J Clin Oncol

      Volume: 40 Pages: 620-626

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Differential survival following trastuzumab treatment based on quantitative HER2 expression and HER2 homodimers in aclinic-based cohort of patients with metastatic breast cancer.2010

    • Author(s)
      Toi M, Sperinde J, Huang W, Saji S, Winslow J, Jin X, Tan Y, Ohno S, Nakamura S, Iwata H, Masuda N, Aogi K, Morita S, Petropoulos C, Bates M
    • Journal Title

      BMC Cancer 10

      Pages: 56-56

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sample sizes for a robust ranking and selection of genes in microarray experiments.2009

    • Author(s)
      Matsui S, Oura T
    • Journal Title

      Statistics in Medicine 28巻

      Pages: 2801-2816

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Sample size calculations for controlling the distribution of false discovery proportion in microarray experiments.2009

    • Author(s)
      Oura T, Matsui S, Kawakami K
    • Journal Title

      Biostatistics 10巻

      Pages: 694-705

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] A Bayesian hierarchical mixture model for platelet derived growth factor receptor phosphorylation to improve estimation of progression-free survival in prostate cancer.2009

    • Author(s)
      Morita S, Thall PF, Bekele BN, Mathew P
    • Journal Title

      Journal of the Royal Statistical Society(Series C (Applied Statistics)) 59巻

      Pages: 19-34

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] North East Japan Gefitinib Study Group. First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy.2009

    • Author(s)
      Inoue A, Kobayashi K, Usui K, Maemondo M, Okinaga S, Mikami I, Ando M, Yamazaki K, Saijo Y, Gemma A, Miyazawa H, Tanaka T, Ikebuchi K, Nukiwa T, Morita S, Hagiwara K
    • Journal Title

      Journal of Clinical Oncology 27巻

      Pages: 1394-1400

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Sample sizes for a robust ranking and selection of genes in microarray experiments.2009

    • Author(s)
      Matsui S, Oura T.
    • Journal Title

      Statistics in Medicine 28

      Pages: 2801-2816

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sample size calculations for controlling the distribution of false discovery proportion in microarray experiments.2009

    • Author(s)
      Oura T, Matsui S, Kawakami K
    • Journal Title

      Biostatistics 10

      Pages: 694-705

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A Bayesian hierarchical mixture model for platelet derived growth factor receptor phosphorylation to improve estimation of progression-free survival in prostate cancer.2009

    • Author(s)
      Morita S, Thall PF, Bekele BN, Mathew P.
    • Journal Title

      Journal of the Royal Statistical Society, Series C(Applied Statistics) 59

      Pages: 19-34

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Lidocaine concetration in cerebrospinal fluid after epidural administration : a comparison between epidural and combined spinal-epidural anesthesia.2009

    • Author(s)
      Kamiya Y, Kikuchi T, Inagawa G, Miyazaki H, Miura M, Morita S, Goto T.
    • Journal Title

      Anesthesiology 110

      Pages: 1127-1132

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy. 2009 ; 27 : 1394-1400.2009

    • Author(s)
      Inoue A, Kobayashi K, Usui K, Maemondo M, Okinaga S, Mikami I, Ando M, Yamazaki K, Saijo Y, Gemma A, Miyazawa H, Tanaka T, Ikebuchi K, Nukiwa T, Morita S, Hagiwara K ; North East Japan Gefitinib Study Group
    • Journal Title

      Journal of Clinical Oncology 27

      Pages: 1394-1400

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy2009

    • Author(s)
      Inoue A
    • Journal Title

      Journal of Clinical Oncology 27

      Pages: 1394-1400

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Sample size calculations based on ranking and selection in microarray experiments.2008

    • Author(s)
      Matsui S, Zeng S, Yamanaka T, Shaughnessy J
    • Journal Title

      Biometrics 64巻

      Pages: 217-226

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Clustering of significant genes in prognostic studies with microarrays : application to a clinical study for multiple myeloma.2008

    • Author(s)
      Matsui S, Yamanaka T, Barlogie B, Shaughnessy JD Jr, Crowley J
    • Journal Title

      Statistics in Medicine 27巻

      Pages: 1106-1120

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Sample size calculations based on ranking and selection in microarray experiments2008

    • Author(s)
      Matsui S
    • Journal Title

      Biometrics 64

      Pages: 217-226

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Clustering of significant genes in prognostic studies with microarrays : application to a clinical study for multiple myeloma2008

    • Author(s)
      Matsui S
    • Journal Title

      Statistics in Medicine 27

      Pages: 1106-1120

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] マイクロアレーデータの統計解析2008

    • Author(s)
      松井茂之
    • Journal Title

      化学と生物(日本農芸化学会会誌) 46

      Pages: 759-765

    • Related Report
      2008 Annual Research Report
  • [Journal Article] Frequent microsatellite instability in non-Hodgkin lymphomas irresponsive to chemotherapy2008

    • Author(s)
      Miyashita K
    • Journal Title

      Leuk Res 32

      Pages: 1183-1195

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Safety evaluation of oral fluoropyrimidine S-1 for short-and long-term delivery in advanced gastric cancer2008

    • Author(s)
      Yamanaka T
    • Journal Title

      Cancer Chemother Pharmacol 61

      Pages: 335-343

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Exclusive KRAS mutation in microsatellite-unstable human color ectal carcinomas with sequence alterations in the DNA mismatch repair gene, MLH1.2008

    • Author(s)
      Zhao Y
    • Journal Title

      Gene 423

      Pages: 188-193

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Screening of biochemical modulator by tumor cell permeability of doxorubicin2008

    • Author(s)
      Sadzuka Y
    • Journal Title

      International Journal of Pharmaceutics 354

      Pages: 63-69

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Predictive checking for Bayesian interim analyses in clinical trials2008

    • Author(s)
      Daimon T
    • Journal Title

      Contemporary Clinical Trials 29

      Pages: 740-750

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] The mean squared error optimum design criterion for parameter estimation in nonlinear regression models2008

    • Author(s)
      Daimon T
    • Journal Title

      Communications in Statistics, Theory & Methods 37

      Pages: 508-519

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Presentation] がんの分子診断マーカーの臨床開発:現状と課題2010

    • Author(s)
      松井茂之
    • Organizer
      統計関連学会連合大会
    • Place of Presentation
      早稲田大学(招待講演)
    • Year and Date
      2010-09-07
    • Related Report
      2010 Final Research Report
  • [Presentation] がんの分子診断マーカーの臨床開発:現状と課題2010

    • Author(s)
      松井茂之
    • Organizer
      統計関連学会連合大会
    • Place of Presentation
      早稲田大学
    • Year and Date
      2010-09-07
    • Related Report
      2010 Annual Research Report
  • [Presentation] Results of a phase II multicenter study of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.2010

    • Author(s)
      Terashima M, Saze Z, Hosoya A, Takahashi M, Takagane A, Hachiya O, Koeda K, Matsui S, Kusunoki Y, Oohashi W, Fukushima M, Gotoh M
    • Organizer
      2010 Gastrointestinal Cancers Symposium. The American Society of Clinical Oncology
    • Place of Presentation
      Orlando, Florida.
    • Year and Date
      2010-01-22
    • Related Report
      2010 Final Research Report
  • [Presentation] Results of a phase II multicenter study of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer. 2010 Gastrointestinal Cancers Symposium.2010

    • Author(s)
      Terashima M, Saze Z, Hosoya A, Takahashi M, Takagane A, Hachiya O, Koeda K, Matsui S, Kusunoki Y, Oohashi W, Fukushima M, Gotoh M.
    • Organizer
      The American Society of Clinical Oncology
    • Place of Presentation
      Orlando, Florida
    • Related Report
      2009 Annual Research Report
  • [Presentation] 関節型若年性特発性関節炎に対する methotrexate 療法による肝機能障害と消化器症状に及ぼす遺伝子多型の検討2009

    • Author(s)
      柳町昌克, 成戸拓也, 原拓磨, 菊地雅子, 岸崇之, 原良紀, 宮前多佳子, 今川智之, 森雅亮, 金子徹治, 森田智視, 横田俊平
    • Organizer
      第19回日本小児リウマチ学会総会・学術集会
    • Place of Presentation
      京都
    • Related Report
      2009 Annual Research Report
  • [Presentation] 関節型若年性特発性関節炎(JIA)に対する methotrexate 療法による有効性と副作用に関する薬理遺伝学的検討.2009

    • Author(s)
      柳町昌克, 成戸拓也, 原拓磨, 岸崇之, 菊地雅子, 原良紀, 宮前多佳子, 今川智之, 森雅亮, 金子徹治, 森田智視, 横田俊平
    • Organizer
      第30回日本臨床薬理学会年会
    • Place of Presentation
      横浜
    • Related Report
      2009 Annual Research Report
  • [Presentation] がんの分子診断研究:FDRは有用か?2008

    • Author(s)
      松井茂之
    • Organizer
      2008年度日本計量生物学会年会特別セッション
    • Place of Presentation
      筑波大学
    • Year and Date
      2008-06-05
    • Related Report
      2010 Final Research Report
  • [Presentation] がんの分子診断研究 : FDRは有用か?2008

    • Author(s)
      松井茂之
    • Organizer
      2008年度日本計量生物学会年会特別セッション
    • Place of Presentation
      筑波大学
    • Year and Date
      2008-06-05
    • Related Report
      2008 Annual Research Report
  • [Presentation] Gefitinib combined survival analysis of the mutation positives from the prospective phase II trials (I-CAMP).2008

    • Author(s)
      Morita S.
    • Organizer
      American Society of Clinical Oncology.
    • Place of Presentation
      Chicago.
    • Year and Date
      2008-05-30
    • Related Report
      2010 Final Research Report
  • [Presentation] Gefitinib combined survival analysis of the mutation positives from the prospective phase II trials (I-CAMP)2008

    • Author(s)
      Morita S
    • Organizer
      American Society of Clinical Oncology
    • Place of Presentation
      米国シカゴ
    • Related Report
      2008 Annual Research Report
  • [Presentation] First-line gefitinib for poor PS patients with EGFR mutations2008

    • Author(s)
      Kobayashi K
    • Organizer
      American Society of Clinical Oncology
    • Place of Presentation
      米国シカゴ
    • Related Report
      2008 Annual Research Report
  • [Presentation] Influence of mu-opioid receptor polymorphism on adverse drug effect of oxycodone and fentanyl in Japanese lung cancer patients2008

    • Author(s)
      Uchida S
    • Organizer
      IXth World Conference on Clinical Pharmacology and Therapeutics
    • Place of Presentation
      カナダ、ケベック
    • Related Report
      2008 Annual Research Report
  • [Remarks] ホームページ等

    • Related Report
      2010 Final Research Report

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Published: 2008-04-01   Modified: 2016-04-21  

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