Data integration and standardization of the Asian transplantation registry

• Project/Area Number: 17K08911
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical sociology
• Research Institution: Nagoya University
• Principal Investigator: Kuwatsuka Yachiyo 名古屋大学, 医学部附属病院, 病院講師 (00720509)
• Co-Investigator(Kenkyū-buntansha): 飯田 美奈子 愛知医科大学, 医学部, 講師 (70513290)
• Project Period (FY): 2017-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000); Fiscal Year 2019: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000); Fiscal Year 2018: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2017: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
• Keywords: 国際データ標準 / CDISC / レジストリデータ / 造血細胞移植 / レジストリ / レギュラトリサイエンス

Outline of Final Research Achievements

To collect the Asian-Pacific Blood and Marrow Transplantation Group (APBMT) registry data with an electronic data capture (EDC) system, the database of the registry was improved. To integrate data that are collected in multiple ways, programs that converts US registry format to APBMT legacy data, legacy data to EDC format, and back from EDC format to researcher-friendly legacy format were developed. Further, EDC data format were mapped to the Clinical Data Interchange Standards Consortium (CDISC) format, which is the international data standard tha are used when applying new drug application for regulatories.

Academic Significance and Societal Importance of the Research Achievements

移植レジストリデータの国際データ標準化は、移植領域における規制当局申請への活用が期待され、さらにレギュラトリサイエンス研究分野への応用可能性に直結する。国際展開したアジアの移植レジストリを国際データ標準化することにより、移植サーベイを含めたグローバルスタディが加速化され、世界への貢献が期待される。移植レジストリのCDISC 実装化可能性に関する知見の蓄積は、細胞療法領域レジストリにおける今後の国際調和に向けた意義を持つ。

Research Products

• [Journal Article] Trends in disease indications for hematopoietic stem cell transplantation in the Asia-Pacific region: A report of the Activity Survey 2017 from APBMT (2022)
  • Author(s): Iida M, Liu K, Huang XJ, Depei W, Kuwatsuka Y, Moon JH, Dodds A, Wilcox L, Ko BS, Hamidieh AA, Ho KW, Ungkanont A, Ho A, Farzana T, Sim J, Man HV, Akter M, Abeysinghe P, Bravo MR, Gyi AA, Poudyal BS, Batshkh K, Srivastava A, Okamoto S, Atsuta Y
  • Journal Title: Blood Cell Ther. Volume: 5(4) Issue: 3 Pages: 87-98
  • DOI: 10.31547/bct-2022-002
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Antithymocyte Globulin Potentially Could Overcome an Adverse Effect of Acute Graft-versus-Host Disease in Matched-Related Peripheral Blood Stem Cell Transplantation (2022)
  • Author(s): Miyao K, Kuwatsuka Y, Murata M, Nagafuji K, Teshima T, Takeuchi Y, Shiratori S, Najima Y, Uchida N, Tanaka M, Sawa M, Ota S, Fukuda T, Ozawa Y, Kako S, Kawakita T, Ara T, Tanaka J, Kanda Y, Atsuta Y, Kanda J, Terakura S
  • Journal Title: Transplantation and Cellular Therapy Volume: 28 Issue: 3 Pages: 153.e1-153.e11
  • DOI: 10.1016/j.jtct.2021.12.009
  • Peer Reviewed
• [Journal Article] Use of unapproved or off-label drugs in Japan for the treatment of graft-versus-host disease and post-transplant viral infection (2020)
  • Author(s): Kuwatsuka Y, Atsuta Y, Hirakawa A, Uchida N, Inamoto Y, Najima Y, Ikegame K, Eto T, Ozawa Y, Ichinohe T, Inoue M, Kimura T, Okamoto S, Miyamura K, Fukuda T
  • Journal Title: International Journal of Hematology Volume: 112 Issue: 6 Pages: 841-850
  • DOI: 10.1007/s12185-020-02972-0
  • Peer Reviewed
• [Journal Article] Prospective Phase 2 Study of Umbilical Cord Blood Transplantation in Adult Acute Leukemia and Myelodysplastic Syndrome (2020)
  • Author(s): Terakura S, Nishida T, Sawa M, Kato T, Miyao K, Ozawa Y, Kohno A, Onishi Y, Fukuhara N, Kasai M, Fujii N, Yokoyama H, Iida H, Kanemura N, Fujieda A, Ago H, Tsutsumi Y, Nakamura F, Yago K, Moriuchi Y, Ota S, Ohashi H, Yanagisawa A, Suzuki R, Kuwatsuka Y, Atsuta Y, Miyamura K, Murata M
  • Journal Title: Biology of Blood and Marrow Transplantation Volume: 26 Issue: 1 Pages: 139-144
  • DOI: 10.1016/j.bbmt.2019.09.021
  • Peer Reviewed
• [Journal Article] Time-Varying Effects of Graft Type on Outcomes for Patients with Acute Myeloid Leukemia Undergoing Allogeneic Hematopoietic Cell Transplantation (2020)
  • Author(s): Yanada M, Konuma T, Yamasaki S, Kuwatsuka Y, Masuko M, Tanaka M, Ozawa Y, Toya T, Fukuda T, Ota S, Sawa M, Uchida N, Nakamae H, Eto T, Kanda J, Takanashi M, Kanda Y, Atsuta Y, Yano S.
  • Journal Title: Biology of Blood and Marrow Transplantation Volume: 26 Issue: 2 Pages: 307-315
  • DOI: 10.1016/j.bbmt.2019.09.036
  • Peer Reviewed
• [Journal Article] Analysis of glutathione S-transferase and cytochrome P450 gene polymorphism in recipients of dose-adjusted busulfan-cyclophosphamide conditioning (2020)
  • Author(s): Terakura S, Onizuka M, Fukumoto M, Kuwatsuka Y, Kohno A, Ozawa Y, Miyamura K, Inagaki Y, Sawa M, Atsuta Y, Suzuki R, Naoe T, Morishita Y, Murata M
  • Journal Title: Int J Hematol Volume: 111 Issue: 1 Pages: 84-92
  • DOI: 10.1007/s12185-019-02741-8
  • Peer Reviewed
• [Journal Article] Predictors of Loss to Follow-Up Among Pediatric and Adult Hematopoietic Cell Transplantation Survivors: A Report from the Center for International Blood and Marrow Transplant Research (2020)
  • Author(s): Buchbinder D, Brazauskas R, Bo-Subait K, Ballen K, Parsons S, John T, Hahn T, Sharma A, Steinberg A, D'Souza A, Kumar AJ, Yoshimi A, Wirk B, Shaw B, Freytes C, LeMaistre C, Bredeson C, Dandoy C, Almaguer D, Marks DI, Szwajcer D, Hale G, Kuwatsuka Y, Inamoto Y, Khera N, Hashmi S, Wood W, Saber W, et al.
  • Journal Title: Biology of Blood and Marrow Transplantation Volume: 26 Issue: 3 Pages: 553-561
  • DOI: 10.1016/j.bbmt.2019.11.003
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Prospective evaluation of alternative donor from unrelated donor and cord blood in adult acute leukemia and myelodysplastic syndrome (2020)
  • Author(s): Terakura S, Nishida T, Sawa M, Kato T, Miyao K, Ozawa Y, Goto T, Kohno A, Ozeki K, Onishi Y, Fukuhara N, Fujii N, Yokoyama H, Kasai M, Iida H, Kanemura N, Endo T, Ago H, Onizuka M, Iyama S, Nawa Y, Nakamae M, Nagata Y, Kurahashi S, Tomiya Y, Yanagisawa A, Suzuki R, Kuwatsuka Y, Atsuta Y, Miyamura K, Murata M
  • Journal Title: Bone Marrow Transplantation Volume: -- Issue: 7 Pages: 1399-1409
  • DOI: 10.1038/s41409-020-0859-8
  • NAID: 120006891238
  • Peer Reviewed
• [Journal Article] Unit selection for umbilical cord blood transplantation for adults with acute myeloid leukemia in complete remission: a Japanese experience (2019)
  • Author(s): Yanada M, Konuma T, Kuwatsuka Y, Kondo T, Kawata T, Takahashi S, Uchida N, Miyakoshi S, Tanaka M, Ozawa Y, Sawa M, Nakamae H, Aotsuka N, Kanda J, Takanashi M, Kanda Y, Atsuta Y, Yano S.
  • Journal Title: Bone Marrow Transplantation Volume: 54 Issue: 11 Pages: 1789-1798
  • DOI: 10.1038/s41409-019-0539-8
  • Peer Reviewed
• [Journal Article] Impact of cytogenetic abnormalities on outcomes of adult Philadelphia-negative acute lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation: a study by the Acute Leukemia Working Committee of the Center for International Blood and Marrow Transplant Research (2019)
  • Author(s): Lazaryan A, Dolan M, Zhang MJ, Wang HL, Kharfan-Dabaja MA, Marks DI, Bejanyan N, Copelan E, Maijhail N, Waller EK, Chao N, Prestidge T, Nishihori T, Kebriaei P, Inamoto Y, Hamilton B, Kuwatsuka Y, Seo S, Ustun C, Politikos I, Lazarus HM, Saber W, Sandmaier BM, de Lima M, Litzow M, Bachanova V, Weisdorf D, et al.
  • Journal Title: Haematologica Volume: -- Issue: 5 Pages: 1329-1338
  • DOI: 10.3324/haematol.2019.220756
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Allogeneic haematopoietic cell transplantation for adult acute myeloid leukaemia in second remission: a retrospective study of the Adult Acute Myeloid Leukaemia Working Group of the Japan Society for Haematopoietic Cell Transplantation (JSHCT) (2018)
  • Author(s): Konuma T, Yanada M, Yamasaki S, Kuwatsuka Y, Fukuda T, Kobayashi T, Ozawa Y, Uchida N, Ota S, Hoshino T, Takahashi S, Kanda Y, Ueda Y, Takanashi M, Kanda J, Ichinohe T, Atsuta Y, Yano S.
  • Journal Title: Br J Haematol Volume: 182 Issue: 2 Pages: 245-250
  • DOI: 10.1111/bjh.15399
  • Peer Reviewed
• [Journal Article] Country-Level Macroeconomic Indicators Predict Early Post-Allogeneic Hematopoietic Cell Transplantation Survival in Acute Lymphoblastic Leukemia: A CIBMTR Analysis (2018)
  • Author(s): Wood WA, Brazauskas R, Hu ZH, Abdel-Azim H, Ahmed IA, Aljurf M, Badawy S, Beitinjaneh A, George B, Buchbinder D, Cerny J, Dedeken L, Diaz MA, Freytes CO, Ganguly S, Gergis U, Almaguer DG, Gupta A, Hale G, Hashmi SK, Inamoto Y, Kamble RT, Adekola K, Kindwall-Keller T, Knight J, Kumar L, Kuwatsuka Y, Atsuta Y, et al.
  • Journal Title: Biol Blood Marrow Transplant Volume: 24 Issue: 9 Pages: 1928-1935
  • DOI: 10.1016/j.bbmt.2018.03.016
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] GvHD prophylaxis after single-unit reduced intensity conditioning cord blood transplantation in adults with acute leukemia (2017)
  • Author(s): Terakura S, Kuwatsuka Y, Yamasaki S, Wake A, Kanda J, Inamoto Y, Mizuta S, Yamaguchi T, Uchida N, Kouzai Y, Aotsuka N, Ogawa H, Kanamori H, Nishiwaki K, Miyakoshi S, Onizuka M, Amano I, Fukuda T, Ichinohe T, Atsuta Y, Murata M, Teshima T
  • Journal Title: Bone Marrow Transplant Volume: 52 Issue: 9 Pages: 1261-1267
  • DOI: 10.1038/bmt.2017.116
  • NAID: 120006367975
  • Peer Reviewed
• [Journal Article] Prognostic value of genetic mutations in adolescent and young adults with acute myeloid leukemia (2017)
  • Author(s): Kuwatsuka Y、Asou N、Ohtake S、Miyawaki S、Miyazaki Y、Sakura T、Ozawa Y、Usui N、Kanamori H、Ito Y、Imai K、Suehiro Y、Kobayashi S、Kitamura K、Sakaida E、Ogawa S、Naoe T、Hayashi Y、Horibe K、Manabe A、Mizutani S、Adachi S、Kiyoi H et al.
  • Journal Title: International Journal of Hematology Volume: 107 Issue: 2 Pages: 201-210
  • DOI: 10.1007/s12185-017-2340-z
  • NAID: 120006473552
  • Peer Reviewed
• [Journal Article] Acute myeloid leukemia in adolescents and young adults: from the viewpoint of physicians (2017)
  • Author(s): 鍬塚八千代
  • Journal Title: Rinsho Ketsueki Volume: 58 Issue: 8 Pages: 1047-1052
  • DOI: 10.11406/rinketsu.58.1047
  • NAID: 130006067959
  • ISSN: 0485-1439, 1882-0824
  • Peer Reviewed
• [Presentation] 臨床的疑問をいかに臨床研究に繋げるか～２群の比較をテーマに考える～ (2022)
  • Author(s): 鍬塚八千代
  • Organizer: 第44回日本造血・免疫細胞療法学会総会
  • Invited
• [Presentation] Data integration and standardization: The APBMT Outcome Registry Data (2021)
  • Author(s): Yachiyo Kuwatsuka
  • Organizer: APBMT 2021 Virtual
  • Int'l Joint Research / Invited
• [Presentation] 同種造血細胞移植サバイバーにおけるネット生存率とConditional Survival：移植レジストリ解析 (2021)
  • Author(s): 鍬塚 八千代、伊藤 秀美、田渕 健、小沼 貴晶、内田 直之、土岐 典子、小澤 幸泰、池亀 和博、福田 隆浩、一戸 辰夫、木村 文彦、諫田 淳也、熱田 由子、松尾 恵太郎
  • Organizer: 第43回日本造血細胞移植学会総会
• [Presentation] Introduction to the APBMT Registry - Challenges and Successes (2020)
  • Author(s): Minako Iida
  • Organizer: The 25th AnnualCongress of APBMT 2020 Virtual
  • Int'l Joint Research / Invited
• [Presentation] コンパクトARO データセンターにおけるパッケージ型特定臨床研究支援の提供 (2020)
  • Author(s): 鍬塚八千代、木下文恵、林直子、川影美千代、西村千穂、上島裕子、森井智一、渡会康子、杉浦富美子、中村祥子、小林由美子、中村真由美、片山朱美、西脇聡史、安藤雄一、安藤昌彦
  • Organizer: 日本臨床試験学会第11回学術集会総会
• [Presentation] CBT and UBMT comparison in adult aplastic anemia (2018)
  • Author(s): Yachiyo Kuwatsuka
  • Organizer: The International Congress of BMT
  • Int'l Joint Research / Invited