Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study

Fumihiro Shoji, Takanori Yamashita, Fumihiko Kinoshita, Shinkichi Takamori, Takatoshi Fujishita, Ryo Toyozawa, Kensaku Ito, Koji Yamazaki, Naoki Nakashima, Tatsuro Okamoto

研究成果: ジャーナルへの寄稿学術誌査読

抄録

Introduction Immunotherapy is the fourth leading therapy for lung cancer following surgery, chemotherapy and radiotherapy. Recently, several studies have reported about the potential association between the gut microbiome and therapeutic response to immunotherapy. Nevertheless, the specific composition of the gut microbiome or combination of gut microbes that truly predict the efficacy of immunotherapy is not definitive. Methods and analysis The present multicentre, prospective, observational study aims to discover the specific composition of the gut microbiome or combination of gut microbes predicting the therapeutic response to immunotherapy in lung cancer using artificial intelligence. The main inclusion criteria are as follows: (1) pathologically or cytologically confirmed metastatic or postoperative recurrent lung cancer including non-small cell lung cancer and small cell lung cancer; (2) age≥20 years at the time of informed consent; (3) planned treatment with immunotherapy including combination therapy and monotherapy, as the first-line immunotherapy; and (4) ability to provide faecal samples. In total, 400 patients will be enrolled prospectively. Enrolment will begin in 2021, and the final analyses will be completed by 2024. Ethics and dissemination The study protocol was approved by the institutional review board of each participating centre in 2021 (Kyushu Cancer Center, IRB approved No. 2021-13, 8 June 2021 and Kyushu Medical Center, IRB approved No. 21-076, 31 August 2021). Study results will be disseminated through peer-reviewed journals and national and international conferences. Trial registration number UMIN000046428.

本文言語英語
論文番号e061674
ジャーナルBMJ open
12
6
DOI
出版ステータス出版済み - 6月 8 2022

!!!All Science Journal Classification (ASJC) codes

  • 医学(全般)

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