Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study
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 composit...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e061674.full |
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| author | Ryo Toyozawa Fumihiro Shoji Takanori Yamashita Fumihiko Kinoshita Shinkichi Takamori Takatoshi Fujishita Kensaku Ito Koji Yamazaki Naoki Nakashima Tatsuro Okamoto |
| author_facet | Ryo Toyozawa Fumihiro Shoji Takanori Yamashita Fumihiko Kinoshita Shinkichi Takamori Takatoshi Fujishita Kensaku Ito Koji Yamazaki Naoki Nakashima Tatsuro Okamoto |
| author_sort | Ryo Toyozawa |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-da225ab746d64addbe74b8a682a23a0d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-da225ab746d64addbe74b8a682a23a0d2025-01-27T19:25:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-061674Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational studyRyo Toyozawa0Fumihiro Shoji1Takanori Yamashita2Fumihiko Kinoshita3Shinkichi Takamori4Takatoshi Fujishita5Kensaku Ito6Koji Yamazaki7Naoki Nakashima8Tatsuro Okamoto9Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, JapanDepartment of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, JapanMedical Information Center, Kyushu University, Fukuoka, JapanDepartment of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, JapanDepartment of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, JapanDepartment of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, JapanDepartment of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, JapanDepartment of Thoracic Surgery, National Hospital Organisation Kyushu Medical Center, Fukuoka, JapanMedical Information Center, Kyushu University, Fukuoka, JapanDepartment of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, JapanIntroduction 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.https://bmjopen.bmj.com/content/12/6/e061674.full |
| spellingShingle | Ryo Toyozawa Fumihiro Shoji Takanori Yamashita Fumihiko Kinoshita Shinkichi Takamori Takatoshi Fujishita Kensaku Ito Koji Yamazaki Naoki Nakashima Tatsuro Okamoto Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study BMJ Open |
| title | Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study |
| title_full | Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study |
| title_fullStr | Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study |
| title_full_unstemmed | Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study |
| title_short | Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study |
| title_sort | artificial intelligence derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer protocol for a multicentre prospective observational study |
| url | https://bmjopen.bmj.com/content/12/6/e061674.full |
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