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© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

The use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs lacks patient experience and perspectives. This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) in patients with gastrointestinal cancer, lung cancer and malignant pleural mesothelioma treated with regimens containing ICIs.

Methods and analysis

This is an ongoing, multicentre, observational study in Japan. Eligible patients must be at least 20 years old and have been diagnosed with lung cancer, malignant pleural mesothelioma or gastrointestinal cancer and plan to use ICIs. Participants will install the electronic PRO (ePRO) application and report adverse events via ePRO using PRO-CTCAE once weekly for up to 48 weeks. A registry will be established using background information obtained from medical records. The sample size is determined by 1 year projection without using statistical methods. Statistical analyses will include point estimates and 95% CIs for the incidence of each adverse event by cancer type and regimen at each time point.

Ethics and dissemination

This research will be conducted per the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, and the revised Personal Information Protection Law. The study protocol was approved by the Ethics Committee (approval ID T2021-0180) of Tokyo Medical University Hospital on 15 October 2021.

Registration details

The study began enrolling patients in December 2021. The target enrolment is 260; as of October 2022, 141 have been enrolled, and the enrolment is scheduled to end on 30 June 2023.

Trial registration number

UMIN000046418

Details

Title
Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study
Author
Hirata, Taiki 1   VIAFID ORCID Logo  ; Kawaguchi, Takashi 2   VIAFID ORCID Logo  ; Azuma, Kanako 1 ; Torii, Ayako 1 ; Usui, Hiroaki 3 ; Soan Kim 4 ; Hayama, Tatsuya 5 ; Hirate, Daisuke 6 ; Kawahara, Yosuke 7 ; Kumihashi, Yuki 8 ; Chisaka, Tomomi 9 ; Wako, Tetsuya 10 ; Yoshimura, Akinobu 11 ; Miyaji, Tempei 12 ; Yamaguchi, Takuhiro 12 

 Department of Pharmacy, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan 
 Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, Japan; Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan 
 Department of Pharmacy, Kyorin University Hospital, Mitaka, Japan 
 Department of Pharmacy, Juntendo University Nerima Hospital, Nerima-ku, Japan 
 Department of Pharmacy, Nihon University Itabashi Hospital, Itabashi-ku, Japan 
 Department of Pharmacy, Teine Keijinkai Hospital, Sapporo, Japan 
 Department of Pharmacy, JR Tokyo General Hospital, Shibuya-ku, Japan 
 Department of Pharmacy, Tokushima Red Cross Hospital, Komatsushima, Japan 
 Department of Pharmacy, University of Miyazaki Hospital, Miyazaki-gun, Japan 
10  Department of Pharmacy, Nippon Medical School Hospital, Bunkyo-ku, Japan 
11  Department of Clinical Oncology, Outpatient Chemotherapy Center, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan 
12  Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan 
First page
e073724
Section
Oncology
Publication year
2023
Publication date
2023
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2892310670
Copyright
© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.