Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Toshihiko Masui, Tetsuhide Ito, Izumi Komoto, Shinsuke Kojima, Takuji Okusaka, Yasushi Ichikawa, Yusuke Kinugasa, Norihiro Kokudo, Atsushi Kudo, Akihiro Sakurai, Kenichi Sugihara, Hiroshi Date, Ken Haruma, Susumu Hijioka, Koichi Hirata, Hiroo Yamano, Motohiro Sakamine, Takashi Kikuchi, Masanori Fukushima, Masayuki Imamura and Shinji Uemoto
Introduction: Both the diagnosis and the treatment of patients with neuroendocrine neoplasm (NEN) have recently improved globally. Since little data has been presented on the current situation of NEN treatment in Japan, Japan Neuroendocrine Tumor Society (JNETS) established the Japan NEN Registry study and constructed a registry of Japanese NEN patients with a primary site of the pancreas gastrointestinal tract, lungs, bronchi, and thymus in order to clarify the current status of NEN treatment in Japan.
Methods and analysis: The Japan NEN Registry study is a large, multi-institutional prospective cohort study designed by JNETS to clarify actual clinical practice and corresponding outcomes for patients with pathologically diagnosed NENs. At enrollment, demographic characteristics, baseline values and survival event information are reported in an electronic case report form via website. The primary endpoint is overall survival time starting from the date of diagnosis, while the secondary endpoint is progression-free survival starting from the first date of each treatment.
Ethics and dissemination: This study is being conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Clinical Research.
The protocol of this cohort study was created in December 2014 and approved by the ethics review committee of Kyoto University Hospital (version 1.0 approval no. E2383, dated Jan 5, 2015). It was subsequently revised to collect treatment information and follow-up clinical outcomes in December 2018, and the ethics review committee of Kyoto University Hospital approved the protocol (Approval No. R1857-1, date April 19, 2019), and the individual institutional review boards of all participating facilities approved this study (TRIAL REGISTRATION: UMIN-CTR: UMIN000016380). The results of this study will be submitted to peer-reviewed international papers.
Trial registration: UMIN-CTR: UMIN000016380
Strengths and limitations of this study:
• This registration is proposed to provide real-time information on the status of NEN patients in Japan which has not been elucidated so far.
• We intend to prospectively collect information on treatments for these patients with corresponding outcomes.
• This study allows quantitative, descriptive, and comparative analyses, which will evaluate associations among risk factors, treatment, and outcomes for NEN in Japan.