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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030437
Receipt No. 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

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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
Email 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
Email in2145@osaka-med.ac.jp

Sponsor
Institute Osaka medical college
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034704

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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