UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043045 |
|---|---|
| Receipt number | 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 | 2024/01/22 14:26:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sakata-1027@hotmail.co.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2025 | Year | 09 | Month | 30 | 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)
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
Analysis of relationship with food intake questionnaire results
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.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 |
