UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030437 |
|---|---|
| Receipt number | R000034704 |
| Scientific Title | The study of relationship between Immune-related adverse events with immune checkpoint blockade and microbiota change |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2017/12/17 19:40:23 |
* 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
The study of relationship between Immune-related adverse events with immune checkpoint blockade and microbiota change
Acronym
The effect of immune checkpoint blockade on microbiota
Scientific Title
The study of relationship between Immune-related adverse events with immune checkpoint blockade and microbiota change
Scientific Title:Acronym
The effect of immune checkpoint blockade on microbiota
Region
| Japan |
Condition
Condition
gastric cancer, non-small-cell lung cancer
Classification by specialty
| Gastroenterology | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Immune checkpoint blockade thought to have low toxicity
to cells. So immune system or microbiota may have greater involvement with enteritis.We investigate that the effect of immune checkpoint blockade on microbiota.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbiota in stool were examined using a next-generation high-speed sequencer before underwent chemotherapy and after two rounds of chemotherapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Capsule Endoscopy , Colonoscopy
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
The man and woman who will underwent chemotherapy using an immune checkpoint blockade for non-small-cell lung cancer, gastric cancer or it was obtained its consent for this study in used one twenty years or older.
Key exclusion criteria
The person who was not obtained consent of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Hirata |
Organization
Osaka Medical college
Division name
Second Department of Internal Medicine
Zip code
Address
2-7 Daigakumachi, Takatsuki City, Osaka, 569-0801, Japan
TEL
072-683-1221
in2145@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Hirata |
Organization
Osaka Medical college
Division name
Second Department of Internal Medicine
Zip code
Address
2-7 Daigakumachi, Takatsuki City, Osaka, 569-0801, Japan
TEL
072-683-1221
Homepage URL
in2145@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034704
