Department of Pharmacy, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan.
Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, Japan
BMJ Open. 2023 Nov 22;13(11):e073724. doi: 10.1136/bmjopen-2023-073724.
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.
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.
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.
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.
UMIN000046418.
免疫检查点抑制剂（ICIs）在癌症治疗中的应用正在迅速扩大。ICI 具有独特的安全性特征，其特点是免疫相关不良事件（irAEs）。ICI 的安全性缺乏患者的经验和观点。本研究主要旨在使用包含 ICI 的方案治疗胃肠道癌、肺癌和恶性胸膜间皮瘤患者的患者报告结局版通用术语标准（PRO-CTCAE）获得描述性研究 irAEs 状况的数据库。
这是一项正在进行的、多中心、观察性研究，在日本进行。合格的患者必须年满 20 岁，并已被诊断患有肺癌、恶性胸膜间皮瘤或胃肠道癌，并计划使用 ICI。参与者将安装电子患者报告结局（ePRO）应用程序，并使用 PRO-CTCAE 通过 ePRO 每周报告一次不良事件，最长 48 周。将使用从病历中获得的背景信息建立注册。样本量根据没有使用统计方法的 1 年预测确定。统计分析将包括按癌症类型和方案在每个时间点的每个不良事件的发生率的点估计值和 95%置信区间。
本研究将根据赫尔辛基宣言、文部科学省、厚生劳动省发布的生命科学和涉及人类受试者的医学研究伦理指南以及修订后的个人信息保护法进行。研究方案于 2021 年 10 月 15 日获得东京医科大学医院伦理委员会（批准 ID T2021-0180）的批准。
该研究于 2021 年 12 月开始招募患者。目标入组人数为 260 人；截至 2022 年 10 月，已入组 141 人，预计入组将于 2023 年 6 月 30 日结束。
UMIN000046418。
