UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046428 |
|---|---|
| Receipt number | R000052977 |
| Scientific Title | Artificial intelligence-driven specific gut microbiome as a predictive biomarker for the therapeutic response to cancer immunotherapy in lung cancer- a multicenter prospective observational study- |
| Date of disclosure of the study information | 2021/12/21 |
| Last modified on | 2023/07/27 16:53:21 |
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Basic information
Public title
Artificial intelligence-driven specific gut microbiome as a predictive biomarker for the therapeutic response to cancer immunotherapy in lung cancer- a multicenter prospective observational study-
Acronym
Artificial intelligence-driven specific gut microbiome as a predictive biomarker for the therapeutic response to cancer immunotherapy in lung cancer- a multicenter prospective observational study-
Scientific Title
Artificial intelligence-driven specific gut microbiome as a predictive biomarker for the therapeutic response to cancer immunotherapy in lung cancer- a multicenter prospective observational study-
Scientific Title:Acronym
Artificial intelligence-driven specific gut microbiome as a predictive biomarker for the therapeutic response to cancer immunotherapy in lung cancer- a multicenter prospective observational study-
Region
| Japan |
Condition
Condition
Advanced/recurrent lung cancer
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 specific gut microbiome as a predictive biomarker of therapeutic response to cancer immunotherapy in lung cancer patients driving artificial intelligence
Basic objectives2
Others
Basic objectives -Others
To establish the predictive system of therapeutic response to cancer immunotherapy using gut microbiome in lung cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To establish the predictive system of therapeutic response to cancer immunotherapy using gut microbiome in lung cancer
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 or small cell lung cancer
(2) Planned to treat with cancer immunotherapy
(3) Informed consent obtained from patients
Key exclusion criteria
(1) Patients have already received cancer immunotherapy
(2)Inadequate cases judged by doctors
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Shoji |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
8111395
Address
3-1-1 Notame, Minami-ku, Fukuoka
TEL
09054881926
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 Cancer Center
Division name
Department of Thoracic Oncology
Zip code
8111395
Address
3-1-1 Notame, Minami-ku, Fukuoka
TEL
09054881926
Homepage URL
fshoji@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Cancer Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center
Address
3-1-1 Notame, Minami-ku, Fukuoka
Tel
0925413231
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
| 2021 | Year | 12 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) The association between the specific composition and diversity of gut microbiome, and therapeutic response to cancer immunotherapy
(2) Relapse-free 6 months survival according to the diversity and specific species of fecal microbiota
(3) Overall 12 months survival according to the diversity and specific species of fecal microbiota
Management information
Registered date
| 2021 | Year | 12 | Month | 21 | 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=R000052977
