UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051705 |
|---|---|
| Receipt number | R000059008 |
| Scientific Title | Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer |
| Date of disclosure of the study information | 2023/07/24 |
| Last modified on | 2023/07/27 16:52:08 |
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Basic information
Public title
Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer
Acronym
Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer
Scientific Title
Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer
Scientific Title:Acronym
Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present multicenter, 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.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The specific composition of the gut microbiome or combination of gut microbes associated with clinical/graphical therapeutic responses to immunotherapy.
Key secondary outcomes
The specific composition of the gut microbiome or combination of gut microbes associated with immune-related adverse events (irAEs) and The diversity of gut microbes associated with irAEs.
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
i. Pathologically or cytologically confirmed metastatic or postoperative recurrent NSCLC or SCLC.
ii. 20 years old at the time of informed consent.
iii. Planned treatment with immunotherapy including combination regimens and monotherapies as the first immunotherapy.
iv. Ability to provide fecal samples.
v. Provision of written informed consent.
Key exclusion criteria
i. Diseases eligible for definitive chemoradiotherapy.
ii. Patients deemed inappropriate for the study by the investigator.
Target sample size
326
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
811-1395
Address
3-1-1, Notame, Minami-ku, Fukuoka
TEL
092-541-3231
fumshojifumshoji@gmail.com
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
811-1395
Address
3-1-1, Notame, Minami-ku, Fukuoka
TEL
092-541-3231
Homepage URL
fumshojifumshoji@gmail.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
National Hospital Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Review Board
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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
| 2023 | Year | 07 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter, prospective, observational study
Management information
Registered date
| 2023 | Year | 07 | Month | 24 | 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=R000059008
