UMIN-CTR Clinical Trial

Basic information
Public title	Immune checkpoint inhibitors and drug-induced colitis
Acronym	Immune checkpoint inhibitors and drug-induced colitis
Scientific Title	Immune checkpoint inhibitors and drug-induced colitis
Scientific Title:Acronym	Immune checkpoint inhibitors and drug-induced colitis
Region	Japan

Condition
Condition	patients who are going to administered immune checkpoint inhibitor
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will clarify the frequency of endoscopic or histological colitis for immunocheckpoint inhibitor administration. Also, we will clarify what kind of cases will cause colitis.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endoscopic and microscopic colitis occurrence frequency at the sixth administration of immunity checkpoint inhibitor
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patient who is treated at Shiga Medical School Medical School affiliated hospital 2. Patient scheduled to receive an immunity checkpoint inhibitor 3. Age over 20 years old 4. Those who can acquire the consent of trial participation by voluntary intention from the principal in writing
Key exclusion criteria	1. Patients who can not obtain consent 2. Patient undergoing antithrombotic therapy 3. When polyps that were judged to be resected for adaptation at the time of the initial colonoscopy are discovered 4. Patients with brachytherapy embedded for prostate cancer treatment
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shigeki Middle name Last name Bamba
Organization	Shiga University of Medical Science
Division name	Division of Clinical Nutrition
Zip code	520-2192
Address	Otsu, Seta-Tsukinowa, Shiga
TEL	0775482899
Email	sb@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Shigeki Middle name Last name Bamba
Organization	Shiga University of Medical Science
Division name	Division of Clinical Nutrition
Zip code	520-2192
Address	Otsu, Seta-Tsukinowa, Shiga
TEL	0775482899
Homepage URL
Email	sb@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiga University of Medical Science
Address	Seta-Tsukinowa Otsu
Tel	077-548-2544
Email	hqmed2@belle.shiga-med.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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 03 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 20 Day
Date of IRB	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 06 Month 03 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	UCEIS Riley score calprotectin microbiota

Management information
Registered date	2018 Year 06 Month 03 Day
Last modified on	2019 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037463