Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society

Yuichi Ozawa, MD, PhD; Nobuyuki Yamamoto, MD, PhD; Kouji Yamamoto, PhD; Kentaro Ito, MD; Hirotsugu Kenmotsu, MD, PhD; Hidetoshi Hayashi, MD, PhD; Takehito Shukuya, MD, PhD; Daichi Fujimoto, MD, PhD; Shunichi Sugawara, MD, PhD; Seiji Niho, MD, PhD; Yuichiro Ohe, MD, PhD; Hiroaki Okamoto, MD, PhD; Kazuhiko Nakagawa, MD, PhD; Katsuyuki Kiura, MD, PhD; Ichiro Yoshino, MD, PhD; Akihiko Gemma, MD, PhD

JTO Clinical and Research Reports (May 2022)

Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society

Yuichi Ozawa, MD, PhD,
Nobuyuki Yamamoto, MD, PhD,
Kouji Yamamoto, PhD,
Kentaro Ito, MD,
Hirotsugu Kenmotsu, MD, PhD,
Hidetoshi Hayashi, MD, PhD,
Takehito Shukuya, MD, PhD,
Daichi Fujimoto, MD, PhD,
Shunichi Sugawara, MD, PhD,
Seiji Niho, MD, PhD,
Yuichiro Ohe, MD, PhD,
Hiroaki Okamoto, MD, PhD,
Kazuhiko Nakagawa, MD, PhD,
Katsuyuki Kiura, MD, PhD,
Ichiro Yoshino, MD, PhD,
Akihiko Gemma, MD, PhD

Affiliations

Yuichi Ozawa, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan; Corresponding author. Address for correspondence: Yuichi Ozawa, MD, PhD, Internal Medicine III, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8509, Japan.
Nobuyuki Yamamoto, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan
Kouji Yamamoto, PhD: Department of Biostatistics, Yokohama City University Graduate School of Medicine, Kanagawa, Japan
Kentaro Ito, MD: Respiratory Center, Matsusaka Municipal Hospital, Mie, Japan
Hirotsugu Kenmotsu, MD, PhD: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan
Hidetoshi Hayashi, MD, PhD: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan
Takehito Shukuya, MD, PhD: Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
Daichi Fujimoto, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan
Shunichi Sugawara, MD, PhD: Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan
Seiji Niho, MD, PhD: Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Tochigi, Japan
Yuichiro Ohe, MD, PhD: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
Hiroaki Okamoto, MD, PhD: Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, Kanagawa, Japan
Kazuhiko Nakagawa, MD, PhD: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan
Katsuyuki Kiura, MD, PhD: Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan
Ichiro Yoshino, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan; Department of Biostatistics, Yokohama City University Graduate School of Medicine, Kanagawa, Japan; Respiratory Center, Matsusaka Municipal Hospital, Mie, Japan; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan; Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan; Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Tochigi, Japan; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, Kanagawa, Japan; Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan; Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan; Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
Akihiko Gemma, MD, PhD: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan

Journal volume & issue: Vol. 3, no. 5
p. 100317

Abstract

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Introduction: Although data accumulated in clinical trials have higher accuracy compared with real-world data and are irreplaceably valuable, most previous clinical trial data have been left unused. Methods: The Japan Lung Cancer Society (JLCS) asked six clinical trial groups that conducted randomized clinical trials on curative chemoradiation for locally advanced NSCLC to provide data. After obtaining consent from all six groups, data were collected from August 2019 to June 2021. Results: A total of eight trials, JCOG9812, JCOG0301, NJLCG0601, OLCSG0007, WJTOG0105, WJOG5008L, SPECTRA, and TORG1018, were included. More than 3000 data items were integrated into 408 items by adjusting their definitions and units. The total number of collected cases was 1288: median age (range), 66 (30–93) years; sex (male/female) 1064/224; pathological type (squamous cell carcinoma, adenocarcinoma, other NSCLC, and unknown) 517, 629, 138, and 4; and stage IIIA and B, 536 and 752. The median overall survival was 26.0 months, with 2-, 5-, and 10-year survival rates of 53.7%, 24.8%, and 15.2%, respectively, in all enrollments. The median progression-free survival was 9.6 months, with 2-, 5-, and 10-year progression-free survival rates of 23.6%, 14.0%, and 9.4%, respectively. Part of the information in the database has been made available on the JLCS web page, and the JLCS members were provided the right to propose research using the database. Conclusions: The integration and sharing of clinical trial data for research purposes was made real by the nonprofit, academic organization, the JLCS. This database will lead to innovative researches and contribute to the improvement of lung cancer treatment and future research.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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