UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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
Acronym
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
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
advanced/reccurent non-small cell lung cancer patients
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Others
Basic objectives -Others
To analyze the correlation of fecal microbiota profiles and clinico-pathological features, prognosis and immune-related adverse events cased by Atezolizumab immunetherapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(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
Key exclusion criteria
(1) Inadequate cases judged by doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Shoji |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Thoracic Surgery
Zip code
810-8563
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL
092-852-0700
fshoji@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Shoji |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Thoracic Surgery
Zip code
810-8563
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL
092-852-0700
Homepage URL
fshoji@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center, Clinical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Medical Center
Address
1-8-1, Jigyohama, Chuo-ku, Fukuoka
Tel
092-852-0700
fshoji@surg2.med.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(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
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047745
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
