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Annual Report 2024

Division of Biostatistical Research

Taro Shibata, Aya Kuchiba

Introduction

 Our division aims to gain a better understanding of specific research questions and derive deeper insights from collaborative research, through the involvement of both applied research and methodology development, in cooperation with various divisions of National Cancer Center. In addition, as experts in quantitative research methods, we provide consultations on research hypothesis formulation, study design, data collection and management, database design, and data analysis, thereby enhancing the research infrastructure. We closely work with the Biostatistics Division, Center for Research Administration and Support on these activities.

Research Activities

 Methodological Research

  • A paper on statistical methods for evaluating etiologic heterogeneity among cancer subtypes has been resubmitted and is currently under revision.
  • A paper on statistical methods for detecting changes in longitudinal biomarker data from liquid biopsy has been resubmitted and is currently under review.

 Building and Utilizing Research Platform

  • Conducted six consultations (on five distinct projects) on research utilizing omics data in collaboration with bioinformatic experts in the Division of Bioinformatics, Research Institute. One of these projects has been progressed into collaborative research, and a manuscript is currently under submission.
  • Conducted two research seminars on statistical methods, using collaborative research at the Institute for Cancer Control as a case study.
  • Explored methods to utilize clinical trial databases in coordinating with other cancer-related information dissemination platforms and research initiatives, and continued to collaborate with the Division of Cancer Information Service to ensure ongoing information dissemination.

 Collaborative Research

  • A paper applying causal mediation analysis to nested case-control data has been published.
  • Presented the results of a cluster randomized controlled trial on smoking cessation, in which we had been involved since the planning stage, as a co-presenter at ASCO 2024.
  • Published a research paper as a co-author evaluating heterogeneity in the effects of risk factors among cancer subtypes using cohort data, applying a statistical method we had previously developed.
  • Involved in multiple studies evaluating the performance and building evidence for the implementation of endoscopic diagnostic support systems and ultrasound diagnostic support systems using artificial intelligence, starting from the development of the research protocols.
  • Contributed as a co-author to several studies led by investigators at the National Cancer Center, including epidemiological research using biomarkers, studies on smoking cessation, and nationwide survey research on health information.

Education

 Accepted two visiting trainees, each of whom initiated a study on statistical methods, using as case studies the JPHC Study and the INFORM Study 2020, in which we have been involved.

Future Prospects

 In 2024, in addition to methodological research and collaborative projects, we continued to conduct joint consultations with bioinformatics experts. Our division also accepted visiting trainees this year, who initiated studies on statistical methods motivated by collaborative research. We will continue to advance methodological development, pursue new collaborations, and expand into unexplored areas.

List of papers published in 2024

Journal

1. Kitadai R, Yazaki S, Kuchiba A, Yamanaka T, Shiino S, Yamauchi C, Harano K, Saito M, Hirotsu Y, Aiba H, Yoshida T, Hamamoto R, Shimizu C, Shimomura A, Kojima Y, Shimoi T, Momozawa Y, Sudo K, Yoshida M, Sunami K, Hori M, Katanoda K, Shimada Y, Yamashita Y, Kogawa T, Murata T, Fujiwara S, Miyagi Y, Nakagomi H, Tachibana K, Omata M, Ohtake T, Suto A, Onishi T, Naito Y, Yamashita T, Yonemori K, Kohno T, Shiraishi K. Germline Pathogenic Variants and Clinical Outcomes in Asian Patients With Breast Cancer. Cancer science, 116:1048-1058, 2025

2. Jindai K, Saito H, Morino E, Hase R, Yamato M, Sonoda M, Shibata T, Iiyama T. Hospital Preparedness for Conducting Clinical Research During a Pandemic: A Nationwide Survey Among Designated Medical Institutions for Infectious Diseases in Japan. Health security, 23:82-93, 2025

3. Ando Y, Yanagisawa S, Ohno M, Kurihara H, Ito K, Ichimura M, Anjo K, Inaba M, Nagasaka Y, Sadachi R, Shibata T, Okita N, Nakamura K, Matsumoto H, Yoshii Y, Narita Y. Efficacy of radioactive hypoxia-targeting therapeutic agent 64Cu-ATSM on recurrent malignant glioma: a study protocol for a phase-III, investigator-sponsored, randomized controlled trial. Japanese journal of clinical oncology, 55:543-546, 2025

4. Sekiguchi M, Shinmura K, Sumiyama K, Matsuda T, Han KS, Kim HS, Chiu HM, Chang CY, Lee WJJ, Khor CJL, Lau LH, Pattarajierapan S, Khomvilai S, Miyata A, Shibata T, Saito Y. Protocol for a multicenter randomized controlled trial to assess the usefulness of computer-aided detection systems for colonoscopy in colorectal cancer screening in the Asia-Pacific region (project CAD/NCCH2217). Japanese journal of clinical oncology, 2025

5. Toyoshima N, Mizuguchi Y, Takamaru H, Nakamura K, Kakugawa Y, Sakamoto T, Shiroyama M, Kawagoe R, Tsuchiya K, Shinmura K, Ikematsu H, Inaba A, Minakata N, Hotta K, Imai K, Takada K, Ito S, Misawa M, Wakamura K, Kudo SE, Tamai N, Sumiyama K, Ito M, Uraoka T, Tomaru S, Matsuda T, Fujimoto A, Shibata T, Saito Y. The Efficacy of Texture and Color Enhancement Imaging Observation in the Detection of Colorectal Lesions: A Multicenter, Randomized Controlled Trial (deTXIon Study). Gastroenterology, 2025

6. Hamada T, Seki M, Nango E, Shibata T, Imai S, Miyata T. Enhancing effects of exercise and neurofeedback: A systematic review and meta-analysis of computer game-based interventions for pediatric ADHD. Psychiatry research, 348:116447, 2025

7. Kitadai R, Okuma Y, Shibata T, Kohno T, Koyama T. Tissue-agnostic target profiles and treatment efficacy in cancer patients: Insights from the C-CAT clinicogenomic repository. European journal of cancer (Oxford, England : 1990), 220:115380, 2025

8. Momosaka T, Saito J, Otsuki A, Yaguchi-Saito A, Fujimori M, Kuchiba A, Katanoda K, Takaku R, Shimazu T. Associations of Individual Characteristics and Socioeconomic Status With Heated Tobacco Product Harmfulness Perceptions in Japan: A Nationwide Cross-sectional Study (INFORM Study 2020). Journal of epidemiology, 34:411-418, 2024

9. Okamura M, Fujimori M, Otsuki A, Saito J, Yaguchi-Saito A, Kuchiba A, Uchitomi Y, Shimazu T. Patients' perceptions of patient-centered communication with healthcare providers and associated factors in Japan - The INFORM Study 2020. Patient education and counseling, 122:108170, 2024

10. Taguri M, Kuchiba A, Yamaji T, Sawada N, Goto A, Iwasaki M, Tsugane S. Importance of Circulating Leptin and Adiponectin in the Causal Pathways Between Obesity and the Development of Colorectal Cancer in Japanese Men. Journal of epidemiology, 34:563-569, 2024

11. Saito Y, Toyoshima N, Mizuguchi Y, Sakamoto T, Uraoka T, Ikematsu H, Tamai N, Matsuda T, Misawa M, Hotta K, Shibata T. Protocol for a prospective multicenter randomized controlled trial to evaluate the efficacy of texture and color enhancement imaging (TXI) observation in the detection of colorectal lesions (deTXIon study). Japanese journal of clinical oncology, 54:1052-1056, 2024

12. Nakano S, Yamaji T, Hidaka A, Shimazu T, Shiraishi K, Kuchiba A, Saito M, Kunishima F, Nakaza R, Kohno T, Sawada N, Inoue M, Tsugane S, Iwasaki M. Dietary vitamin D intake and risk of colorectal cancer according to vitamin D receptor expression in tumors and their surrounding stroma. Journal of gastroenterology, 59:825-835, 2024

13. Nishihara K, Nakano S, Yamaji T, Goto A, Hidaka A, Shimazu T, Kuchiba A, Saito M, Kunishima F, Nakaza R, Kato I, Sawada N, Inoue M, Tsugane S, Iwasaki M. Height, body mass index, physical activity, and risk of colorectal cancer in relation to expression of insulin receptor: The Japan Public Health Center-based Prospective Study. International journal of cancer, 155:1751-1761, 2024

14. Uneno Y, Mori M, Saito J, Otsuki A, Kuchiba A, Sakurai N, Nakaya N, Fujimori M, Shimazu T. Awareness, information sources, and beliefs regarding palliative care in the general population in Japan: a nationwide cross-sectional survey (INFORM study 2023). Japanese journal of clinical oncology, 54:1171-1179, 2024

15. Nishikawa T, Kakunaga S, Tamura K, Ando M, Ozaki T, Kawai A, Ueda T, Kawasaki M, Tomatsuri S, Okamura N, Kamikura M, Hamada A, Yoshida A, Hirakawa A, Shibata T, Nakamura K, Yonemori K. Efficacy and safety of nivolumab monotherapy in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (OSCAR Trial/NCCH1510). Cancer, 130:3836-3844, 2024

16. Ohba A, Morizane C, Kawamoto Y, Komatsu Y, Ueno M, Kobayashi S, Ikeda M, Sasaki M, Furuse J, Okano N, Hiraoka N, Yoshida H, Kuchiba A, Sadachi R, Nakamura K, Matsui N, Nakamura Y, Okamoto W, Yoshino T, Okusaka T. Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Expressing Biliary Tract Cancer (HERB; NCCH1805): A Multicenter, Single-Arm, Phase II Trial. Journal of clinical oncology, 42:3207-3217, 2024

17. Noguchi E, Yamanaka T, Mukai H, Yamamoto N, Chung CF, Lu YS, Chang DY, Sohn J, Kim GM, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Sudo K, Kojima Y, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. NPJ breast cancer, 10:76, 2024

18. Truong HT, Nakahara S, Nguyen SH, Le CN, Shinichi T, Kuchiba A, Mai TD, Nguyen HT. Factors Associated With Delayed Hospital Arrival After Stroke Onset: An Observational Study in Thanh Hoa Province, Vietnam. Cureus, 16:e73361, 2024