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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032854
Receipt No. R000037463
Scientific Title Immune checkpoint inhibitors and drug-induced colitis
Date of disclosure of the study information 2018/06/03
Last modified on 2018/11/08

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

Public contact
1st name of contact person
1st name
Middle name
Last name Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Clinical Nutrition
Zip code
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
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 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
Anticipated trial start date
2018 Year 06 Month 03 Day
Last follow-up date
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
2018 Year 11 Month 08 Day


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

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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