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
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...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e073724.full |
| _version_ | 1797434865142988800 |
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| author | Takuhiro Yamaguchi Tempei Miyaji Takashi Kawaguchi Kanako Azuma Taiki Hirata Ayako Torii Hiroaki Usui Soan Kim Tatsuya Hayama Daisuke Hirate Yosuke Kawahara Yuki Kumihashi Tomomi Chisaka Tetsuya Wako Akinobu Yoshimura |
| author_facet | Takuhiro Yamaguchi Tempei Miyaji Takashi Kawaguchi Kanako Azuma Taiki Hirata Ayako Torii Hiroaki Usui Soan Kim Tatsuya Hayama Daisuke Hirate Yosuke Kawahara Yuki Kumihashi Tomomi Chisaka Tetsuya Wako Akinobu Yoshimura |
| author_sort | Takuhiro Yamaguchi |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-03-09T10:39:03Z |
| format | Article |
| id | doaj.art-d0e6cac28fb4426f91d6091e6c050f7e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T10:39:03Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-d0e6cac28fb4426f91d6091e6c050f7e2023-12-01T19:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-073724Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort studyTakuhiro Yamaguchi0Tempei Miyaji1Takashi Kawaguchi2Kanako Azuma3Taiki Hirata4Ayako Torii5Hiroaki Usui6Soan Kim7Tatsuya Hayama8Daisuke Hirate9Yosuke Kawahara10Yuki Kumihashi11Tomomi Chisaka12Tetsuya Wako13Akinobu Yoshimura14Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Miyagi, JapanDivision of Survivorship Research, Institute for Cancer Control, National Cancer Center, Tokyo, JapanDepartment of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, JapanDepartment of Pharmacy, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, JapanDepartment of Pharmacy, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, JapanDepartment of Pharmacy, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, JapanDepartment of Pharmacy, Kyorin University Hospital, Mitaka, JapanDepartment of Pharmacy, Juntendo University Nerima Hospital, Nerima-ku, JapanDepartment of Pharmacy, Nihon University Itabashi Hospital, Itabashi-ku, JapanDepartment of Pharmacy, Teine Keijinkai Hospital, Sapporo, JapanDepartment of Pharmacy, JR Tokyo General Hospital, Shibuya-ku, JapanDepartment of Pharmacy, Tokushima Red Cross Hospital, Komatsushima, JapanDepartment of Pharmacy, University of Miyazaki Hospital, Miyazaki-gun, JapanDepartment of Pharmacy, Nippon Medical School Hospital, Bunkyo-ku, JapanDepartment of Clinical Oncology, Outpatient Chemotherapy Center, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, JapanIntroduction 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 UMIN000046418https://bmjopen.bmj.com/content/13/11/e073724.full |
| spellingShingle | Takuhiro Yamaguchi Tempei Miyaji Takashi Kawaguchi Kanako Azuma Taiki Hirata Ayako Torii Hiroaki Usui Soan Kim Tatsuya Hayama Daisuke Hirate Yosuke Kawahara Yuki Kumihashi Tomomi Chisaka Tetsuya Wako Akinobu Yoshimura 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 BMJ Open |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/11/e073724.full |
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