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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043045
Receipt No. R000049142
Scientific Title A prospective observational study of combination of Clostridium butyricum therapy and immune checkpoint inhibitors for thoracic malignancies
Date of disclosure of the study information 2021/01/20
Last modified on 2021/07/19

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Basic information
Public title A prospective observational study of combination of Clostridium butyricum therapy and immune checkpoint inhibitors for thoracic malignancies
Acronym A prospective observational study of combination of Clostridium butyricum therapy and immune checkpoint inhibitors
Scientific Title A prospective observational study of combination of Clostridium butyricum therapy and immune checkpoint inhibitors for thoracic malignancies
Scientific Title:Acronym A prospective observational study of combination of Clostridium butyricum therapy and immune checkpoint inhibitors
Region
Japan

Condition
Condition Thoracic malingancies
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this retrospective study is to analyze changes in fecal microbiota pre and post administration of immune checkpoint inhibitors with and without concomitant use of Clostridium butyricum in patients with thoracic malignancies.
Basic objectives2 Others
Basic objectives -Others Changes in fecal microflora pre and post treatment with immune checkpoint inhibitors
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes in fecal microflora pre and post treatment with immune checkpoint inhibitors
Key secondary outcomes The following survival and safety analyses
Progression free survival(PFS)
6 months PFS rate
1 year survival rate
Overall survival
Objective response rate
Duration of response
Safety (irAEs, diarrhea, etc.)
Survival analysis of cases with antibiotic drugs
Survival analysis of cases with proton pump inhibitor
Analysis of the relationship with the results of food intake questionnaire

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. Histologically or cytologically confirmed thoracic malignancies
2. The patient is scheduled to receive an immune checkpoint inhibitor.
3. History of chemotherapy is not required.
4. Presence of measurable lesions is not required.
5. ECOG PS is not required.
6. Patients must be at least 20 years of age.
7. Expression of PD-L1 is not required.
8. Consent has been obtained in writing.
Key exclusion criteria None
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Tomita
Organization Kumamoto University Hospital
Division name Department of Respiratory Medicine
Zip code 860-8556
Address 1-1-1,Honjo,Chuo-ku,Kumamoto, Japan
TEL 096-373-5012
Email y-tomita@kumadai.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Sakata
Organization Kumamoto University Hospital
Division name Department of Respiratory Medicine
Zip code 860-8556
Address 1-1-1,Honjo,Chuo-ku,Kumamoto, Japan
TEL 096-373-5012
Homepage URL
Email sakata-1027@hotmail.co.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Kumamoto University Hospital
Address 1-1-1,Honjo,Chuo-ku,Kumamoto, Japan
Tel 096-373-5012
Email ski-shien@jimu.kumamoto-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 熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 20 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
2020 Year 12 Month 17 Day
Date of IRB
2021 Year 03 Month 02 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Changes in fecal flora pre and post treatment with immune checkpoint inhibitors, and the following survival and safety analyses will be performed with and without concomitant use of Clostridium butyricum.
Progression-free survival (PFS)
Six-month progression-free survival (PFS)
1-year survival rate
Overall survival (OS)
Overall survival (OS)
Response rate (ORR)
Duration of response (DOR)
Safety (immune-related adverse events, diarrhea, etc.)
Survival analysis in patients using antibiotic therapy
Survival analysis in patients using proton pump inhibitors
Survival analysis in patients using proton pump inhibitors
Analysis of relationship with food intake questionnaire results

Management information
Registered date
2021 Year 01 Month 18 Day
Last modified on
2021 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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