UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of relationship between Immune-related adverse events with immune checkpoint blockade and microbiota change
Title of the study (Brief title)	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	Yuki Hirata
Organization	Osaka Medical college
Division name	Second Department of Internal Medicine
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	Yuki Hirata
Organization	Osaka Medical college
Division name	Second Department of Internal Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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