Unique ID issued by UMIN | UMIN000041822 |
---|---|
Receipt number | R000047745 |
Scientific Title | Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2023/07/27 16:54:09 |
Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Japan |
advanced/reccurent non-small cell lung cancer patients
Pneumology | Chest surgery |
Malignancy
NO
The aim of this study is to clarify the relationship of the response and adverse events of combined- or mono-therapy using Atezolizumab, and the diverstiy or sepcific species of fecal microbiota in non-small cell lung cancer patiennts.
Others
To analyze the correlation of fecal microbiota profiles and clinico-pathological features, prognosis and immune-related adverse events cased by Atezolizumab immunetherapy.
Exploratory
Others
Not applicable
Relapse-free 6 months survival according to the diversity and specific species of fecal microbiota.
Overall 12 months survival according to the diversity and specific species of fecal microbiota.
The incident rates of immune-related adverse events (>= Grade3) according to the diversity and specific species of fecal microbiota.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(1) pathologically or cytologically confirmed non-small cell lung cancer
(2) >= 2o years at the time of informed consent
(3) Planned to treat with Atezolizumab combined chemotheapy or Atezolizumab monotherapy
(4) Informed consent obtained from patients
(5) Cases that feces can be collected
(1) Inadequate cases judged by doctors
60
1st name | Fumihiro |
Middle name | |
Last name | Shoji |
National Hospital Organization Kyushu Medical Center
Department of Thoracic Surgery
810-8563
1-8-1, Jigyohama, Chuo-ku, Fukuoka
092-852-0700
fshoji@surg2.med.kyushu-u.ac.jp
1st name | Fumihiro |
Middle name | |
Last name | Shoji |
National Hospital Organization Kyushu Medical Center
Department of Thoracic Surgery
810-8563
1-8-1, Jigyohama, Chuo-ku, Fukuoka
092-852-0700
fshoji@surg2.med.kyushu-u.ac.jp
National Hospital Organization Kyushu Medical Center, Clinical Research Institute
Chugai Pharmaceutical Co., Ltd.
Profit organization
National Hospital Organization Kyushu Medical Center
1-8-1, Jigyohama, Chuo-ku, Fukuoka
092-852-0700
fshoji@surg2.med.kyushu-u.ac.jp
NO
2020 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2020 | Year | 08 | Month | 06 | Day |
2020 | Year | 09 | Month | 23 | Day |
2020 | Year | 10 | Month | 01 | Day |
2024 | Year | 09 | Month | 30 | Day |
(1) Relapse-free 6 months survival according to the diversity and specific species of fecal microbiota
(2) Overaall 12 months survival according to the diversity and specific species of fecal microbiota
(3) Incident rate of Grade 3 or more immune-related adverse events according to the diversity and specific species of fecal microbiota
2020 | Year | 09 | Month | 17 | Day |
2023 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047745