UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors
Acronym	Analysis of lymphocytes in patients treated with immune checkpoint inhibitors
Scientific Title	Analysis of lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors
Scientific Title:Acronym	Analysis of lymphocytes in patients treated with immune checkpoint inhibitors
Region	Japan

Condition
Condition	patients treated with immune checkpoint inhibitors
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the differences of lymphocyte composition in the intestine and peripheral blood in patients with and without irAE (immune-related Adverse Events) enteritis who treated with immune checkpoint inhibitors
Basic objectives2	Others
Basic objectives -Others	To reveal the clinical characteristic of the patients treated with immune checkpoint inhibitors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	lymphocyte composition of the intestinal tract and peripheral blood in patients treated with immune checkpoint inhibitors
Key secondary outcomes

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	patients treated with immune checkpoint inhibitors
Key exclusion criteria	Pregnant patients
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	0862357218
Email	iwamuromasaya@yahoo.co.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	0862357218
Homepage URL
Email	iwamuromasaya@yahoo.co.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	0862357218
Email	iwamuromasaya@yahoo.co.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

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 08 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	2021 Year 02 Month 05 Day
Date of IRB	2021 Year 02 Month 05 Day
Anticipated trial start date	2021 Year 02 Month 08 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 02 Month 06 Day
Last modified on	2021 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049385